Intuitive Surgical, Inc.
Medical device manufacturer in Sunnyvale, CA.
197510(k) clearances
0PMA approvals
276recalls
Device types
- NAY System, Surgical, Computer Controlled… 147
- GCJ Laparoscope, General & Plastic Surgery 17
- EOQ Bronchoscope (Flexible Or Rigid) 11
- KCT Sterilization Wrap Containers, Trays… 7
- GEI Electrosurgical, Cutting & Coagulation &… 6
- QIH Automated Radiological Image Processing… 2
- HET Laparoscope, Gynecologic (And Accessories) 1
- LKF Cannula, Manipulator/Injector, Uterine 1
- NVE Washer, Cleaner, Automated, Endoscope 1
- OWN Confocal Optical Imaging 1
- LLZ System, Image Processing, Radiological 1
- GAG Stapler, Surgical 1
- FDS Gastroscope And Accessories, Flexible/Rigid 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | 09/08/2026SE |
| K253702 | Intuitive Endoluminal Gastrointestinal System (IG1000)FDS · Traditional | 08/07/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | 07/31/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | 07/14/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | 05/22/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | 03/11/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | 02/24/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | 01/16/2026SE |
| K251763 | IRISegQIH · Traditional | 12/16/2025SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 12/15/2025SE |
| K252069 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 12/02/2025SE |
| K251426 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 10/03/2025SE |
| K252045 | Ion Endoluminal System (IF1000)EOQ · Traditional | 09/23/2025SE |
| K251817 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 09/10/2025SE |
| K251227 | da Vinci Surgical System (IS5000)NAY · Traditional | 09/08/2025SE |
| K252528 | Ion Endoluminal System (IF1000)EOQ · Special | 09/05/2025SE |
| K251324 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 08/29/2025SE |
| K252350 | da Vinci SP Firefly Imaging SystemNAY · Special | 08/28/2025SE |
| K250442 | da Vinci Surgical System, IS5000NAY · Traditional | 07/29/2025SE |
| K251213 | Da Vinci Surgical System (IS5000)NAY · Traditional | 07/23/2025SE |
| K251202 | da Vinci Surgical System (IS5000)NAY · Traditional | 07/16/2025SE |
| K251490 | 8 mm Assist Cannula; 12 mm Assist CannulaGCJ · Traditional | 07/02/2025SE |
| K250674 | Vessel Sealer Curved (480522)NAY · Traditional | 06/13/2025SE |
| K240852 | da Vinci X Surgical System (IS4200); da Vinci Xi Surgical System (IS4000)NAY · Traditional | 06/11/2025SE |
| K250786 | SP Endoscope, 0° (430600)NAY · Traditional | 05/13/2025SE |
| K243714 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 04/24/2025SE |
| K242427 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)NAY · Traditional | 04/01/2025SE |
| K243596 | da Vinci SP SureForm 45 Staplers and Reloads (SP1098)GAG · Traditional | 03/10/2025SE |
| K243582 | da Vinci SP Advanced Access Port Kit (432701)NAY · Traditional | 02/28/2025SE |
| K243641 | da Vinci Surgical System (IS5000)NAY · Traditional | 12/16/2024SE |
| K242461 | IRISegQIH · Traditional | 12/10/2024SE |
| K242318 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 11/26/2024SESU |
| K241814 | da Vinci SP Instruments (SP1098)NAY · Traditional | 11/18/2024SESU |
| K242070 | Ion Endoluminal System (IF 1000)EOQ · Traditional | 09/24/2024SE |
| K241638 | 8mm SureForm 30 Curved-Tip Stapler; 8mm SureForm 30 Stapler; 8mm SureForm 30 ReloadsNAY · Traditional | 09/10/2024SE |
| K241635 | da Vinci E-200 Electrosurgical GeneratorGEI · Traditional | 08/05/2024SE |
| K241360 | Universal Seal (5-12 mm)GCJ · Traditional | 08/05/2024SE |
| K241621 | Da Vinci Monopolar and Bipolar Adapters (378896)GEI · Traditional | 08/02/2024SE |
| K240502 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 07/08/2024SESU |
| K241284 | da Vinci Surgical System (IS5000)NAY · Traditional | 07/03/2024SE |
| K232773 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 06/04/2024SE |
| K240723 | da Vinci Xi Surgical System (IS4000); da Vinci X Surgical System (IS4200)NAY · Traditional | 05/24/2024SE |
| K240135 | Ion Endoluminal System (Ion Fully Articulating Catheter) (IF1000)EOQ · Traditional | 04/03/2024SE |
| K232610 | da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke…NAY · Traditional | 03/14/2024SE |
| K232984 | Ion Endoluminal System (IF1000)EOQ · Traditional | 12/18/2023SE |
| K231798 | da Vinci SP Surgical SystemNAY · Traditional | 11/08/2023SESU |
| K231358 | Universal Seal (5-12 mm)GCJ · Traditional | 07/05/2023SE |
| K231212 | da Vinci E-200 Electrosurgical GeneratorGEI · Traditional | 06/21/2023SE |
| K231224 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY · Special | 05/12/2023SE |
| K230033 | Da Vinci SP Surgical System (SP1098)NAY · Traditional | 04/05/2023SESU |
| K222839 | EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm…NAY · Special | 03/16/2023SE |
| K223039 | da Vinci E-200 Electrosurgical GeneratorGEI · Traditional | 11/28/2022SE |
| K223080 | da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)NAY · Traditional | 11/22/2022SE |
| K222827 | da Vinci Firefly Imaging SystemNAY · Special | 10/20/2022SE |
| K214095 | da Vinci X/Xi (IS4200/IS4000) 8mm Reusable InstrumentsNAY · Traditional | 08/15/2022SE |
| K220299 | Ion Endoluminal System (IF1000)EOQ · Traditional | 06/16/2022SE |
| K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemNAY · Traditional | 02/17/2022SE |
| K220023 | 8mm Monopolar Curved ScissorsNAY · Special | 01/31/2022SE |
| K211997 | 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 ReloadsNAY · Traditional | 12/10/2021SE |
| K212101 | da Vinci SP Firefly Imaging SystemNAY · Traditional | 11/23/2021SE |
| K212747 | Da Vinci SP Surgical SystemNAY · Special | 09/29/2021SESU |
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion…EOQ · Traditional | 08/26/2021SE |
| K211784 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY · Traditional | 08/06/2021SE |
| K211316 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 07/23/2021SESU |
| K211595 | da Vinci SP Surgical System (SP1098)NAY · Special | 06/23/2021SESU |
| K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging SystemNAY · Special | 04/26/2021SE |
| K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X…NAY · Traditional | 02/10/2021SE |
| K202968 | Da Vinci SP Surgical SystemNAY · Traditional | 12/22/2020SESU |
| K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200)NAY · Traditional | 12/10/2020SE |
| K202370 | Ion Endoluminal SystemEOQ · Traditional | 11/16/2020SE |
| K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and AccessoriesNAY · Traditional | 11/12/2020SESU |
| K192717 | da Vinci SP Surgical SystemNAY · Traditional | 09/28/2020SESU |
| K201146 | Ion Endoluminal SystemEOQ · Traditional | 06/26/2020SE |
| K192803 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | 04/29/2020SE |
| K183086 | da Vinci X and Xi Surgical SystemNAY · Traditional | 03/31/2020SE |
| K191529 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | 02/06/2020SE |
| K192367 | Ion Endoluminal SystemEOQ · Traditional | 11/26/2019SE |
| K191280 | E-100 Electrosurgical Generator, SynchroSealNAY · Traditional | 11/14/2019SE |
| K191736 | da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30NAY · Special | 07/26/2019SE |
| K190999 | SureForm 45 Curved Tip, SureForm 45 Gray ReloadNAY · Traditional | 07/12/2019SE |
| K191043 | da Vinci Handheld CameraGCJ · Traditional | 06/06/2019SE |
| K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY · Traditional | 03/14/2019SESU |
| K182643 | IRIS 1.0 SystemLLZ · Traditional | 02/22/2019SE |
| K182188 | Ion Endoluminal System ; Flexision Biopsy NeedleEOQ · Traditional | 02/14/2019SE |
| K183139 | Endoscope Sterilization TrayKCT · Abbreviated | 02/01/2019SE |
| K183224 | SureForm 45, SureForm 45 ReloadsNAY · Traditional | 01/18/2019SE |
| K183107 | Intuitive Surgical Vessel Sealer ExtendNAY · Traditional | 12/11/2018SE |
| K182140 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | 10/24/2018SE |
| K180964 | Endoscope Sterilization TrayKCT · Traditional | 09/28/2018SE |
| K180351 | EndoWrist Mercury Bipolar GrasperNAY · Traditional | 08/07/2018SE |
| K181395 | Universal Cannula Seal (5-12 mm)GCJ · Traditional | 07/27/2018SE |
| K173585 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | 07/19/2018SE |
| K173721 | SureForm 60 and SureForm 60 ReloadsNAY · Traditional | 07/05/2018SE |
| K173906 | da Vinci SP Surgical System, EndoWrist SP Instruments, and AccessoriesNAY · Traditional | 05/31/2018SESU |
| K173415 | EndoWrist 5mm Thoracic GrasperNAY · Traditional | 05/31/2018SE |
| K173337 | Intuitive Surgical EndoWrist Vessel Sealer ExtendNAY · Traditional | 04/26/2018SE |
| K173842 | da Vinci Xi Surgical System, da Vinci X Surgical SystemNAY · Traditional | 04/23/2018SE |
| K180033 | 8mm Monopolar Curved ScissorsNAY · Traditional | 04/06/2018SE |
| K172643 | da Vinci Xi Surgical System; da Vinci X Surgical SystemNAY · Traditional | 01/31/2018SE |
| K170879 | IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30…NAY · Traditional | 09/21/2017SE |
| K170641 | da Vinci S/Si Endoscopes, da Vinci Xi EndoscopesNAY · Traditional | 09/21/2017SE |
| K171632 | da Vinci Xi Surgical SystemNAY · Traditional | 09/19/2017SE |
| K170640 | Endoscope Sterilization TrayKCT · Traditional | 09/17/2017SE |
| K170875 | da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments…NAY · Traditional | 09/12/2017SE |
| K170645 | da Vinci Xi EndoWrist Instruments and AccessoriesNAY · Traditional | 09/11/2017SE |
| K170644 | da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm &…NAY · Traditional | 09/11/2017SE |
| K171699 | da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical SystemNAY · Traditional | 07/28/2017SE |
| K171426 | da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degreeNAY · Special | 06/13/2017SE |
| K170713 | da Vinci Xi Surgical SystemNAY · Traditional | 06/13/2017SE |
| K171388 | EndoWrist Stapler 45 System and Stapler 45 ReloadsNAY · Special | 05/31/2017SE |
| K171294 | da Vinci X Surgical SystemNAY · Special | 05/26/2017SE |
| K170865 | EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site…NAY · Traditional | 04/21/2017SE |
| K170508 | EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30…NAY · Traditional | 03/10/2017SE |
| K162973 | EndoWrist Suction IrrigatorNAY · Traditional | 02/06/2017SE |
| K161178 | da Vinci Xi Surgical SystemNAY · Traditional | 01/19/2017SE |
| K162411 | da Vinci Xi 12 8 mm ReducerNAY · Special | 09/21/2016SE |
| K153276 | da Vinci Xi Surgical SystemNAY · Traditional | 08/07/2016SE |
| K161271 | da Vinci Xi Surgical SystemNAY · Special | 07/11/2016SE |
| K152892 | da Vinci Xi Surgical SystemNAY · Traditional | 04/29/2016SE |
| K152578 | da Vinci Surgical System, Model IS4000NAY · Traditional | 03/30/2016SE |
| K152448 | da Vinci Single-Site Instrument and AccessoriesNAY · Traditional | 03/09/2016SE |
| K152421 | IS4000 Stapler 30 Instrument and Stapler 30 ReloadsNAY · Traditional | 03/04/2016SE |
| K151794 | da Vinci Xi Surgical SystemNAY · Traditional | 01/15/2016SE |
| K151450 | Endoscope Sterilization TrayKCT · Traditional | 01/12/2016SE |
| K153126 | da Vinci Xi Hasson ConeGCJ · Traditional | 12/09/2015SE |
| K152663 | Bladeless Optical ObturatorsGCJ · Special | 10/16/2015SE |
| K150284 | IS4000 da Vinci EndoWrist InstrumentsNAY · Special | 05/15/2015SE |
| K150837 | IS4000 Small Clip Applier, IS4000 Long Bipolar ForcepsNAY · Special | 04/29/2015SE |
| K143132 | IS4000 8mm Harmonic ACE Curved ShearsNAY · Traditional | 04/02/2015SE |
| K142937 | Endoscope Sterilization TrayKCT · Traditional | 02/24/2015SE |
| K142683 | 12 mm Endoscopes and AccessoriesNAY · Traditional | 12/10/2014SE |
| K143217 | 12 mm & Stapler Bladeless ObturatorsNAY · Special | 12/03/2014SE |
| K141075 | Single-Site Wristed Needle DriverNAY · Traditional | 09/26/2014SESU |
| K123329 | Da Vinvi Surgical SystemNAY · Traditional | 09/17/2014SESU |
| K141077 | Da Vinci Firefly Imaging SystemNAY · Traditional | 08/12/2014SE |
| K133942 | Endoscope Sterilization TrayKCT · Abbreviated | 08/01/2014SE |
| K140553 | Endowrist Stapler 45 and Stapler 45 ReloadsNAY · Traditional | 07/25/2014SE |
| K140189 | Endowrist Vessel SealerNAY · Traditional | 06/05/2014SE |
| K133203 | Single-Site PortGCJ · Traditional | 05/09/2014SESU |
| K131962 | Da Vinci SP Surgical System, Endowrist SP Instruments, and AccessoriesNAY · Traditional | 04/17/2014SESU |
| K131861 | Da Vinci Surgical System, Endowrist Instruments and AccessoriesNAY · Traditional | 03/28/2014SE |
| K133845 | 8MM Trocar KitGCJ · Traditional | 02/19/2014SE |
| K133167 | Monopolar Cautery Cord, Bipolar Cautery CordGEI · Traditional | 01/07/2014SE |
| K124031 | Da Vinci Fluorescence Imaging Vision SystemOWN · Traditional | 09/13/2013SE |
| K130266 | Endowrist One Vessel SealerNAY · Traditional | 08/29/2013SE |
| K122532 | Da Vinci Single-Site Instruments and AccessoriesNAY · Traditional | 07/30/2013SESU |
| K130726 | Da Vinci Single-Site Permanent Cautery HookNAY · Special | 06/07/2013SESU |
| K123840 | Connect for Da Vinci Surgical System(S)NAY · Special | 02/14/2013SE |
| K123463 | Intuitive Surgical Da Vinci Si Surgical System SmartpedalsNAY · Special | 12/03/2012SE |
| K121921 | Intuitive Surgical Onsite for Da Vinci Surgical SystemsNAY · Traditional | 10/25/2012SE |
| K113706 | Endowrist Stapler SystemNAY · Traditional | 10/17/2012SE |
| K120215 | Single-Site Medium-Large Clip Applier, Single-Site Cadiere Grasper, Single-Site Fundus…NAY · Special | 04/30/2012SESU |
| K110639 | Endowrist One Vessel SealerNAY · Traditional | 12/28/2011SE |
| K112208 | Intutive Surgical Da Vinci Single Site Instruments and AccessoriesNAY · Traditional | 12/08/2011SESU |
| K112263 | Monopolar Curved Scissors Tip Cover AccessoryNAY · Special | 10/07/2011SE |
| K112584 | 5MM/8MM Harmonic Ace(Tm) Curved Shears, Disposable Harmonic Ace(Tm) Insert, Disposable…NAY · Special | 09/29/2011SE |
| K110451 | Endowrist One Suction/IrrigatorNAY · Traditional | 08/26/2011SE |
| K101581 | Intuitive Surgical Da Vinci S Surgical System with Da Vinci Connect & Da Vinci Onsite…NAY · Traditional | 04/08/2011SE |
| K101743 | 5MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319NAY · Traditional | 02/04/2011SE |
| K101077 | Da Vinci Fluorescence Imaging Vision System, Model FF 100GCJ · Traditional | 02/04/2011SE |
| K093217 | 5 MM Harmonic Ace Instrument (Used with Da Vinci IS1200 & IS2000/IS3000 System)NAY · Traditional | 01/21/2010SE |
| K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000NAY · Traditional | 12/16/2009SE |
| K082497 | Intuitive Surgical Endowrist One Hot Shears InstrumentNAY · Traditional | 05/07/2009SE |
| K081137 | Intuitive Surgical Da Vinci Si Surgical System: Model IS3000NAY · Traditional | 02/18/2009SE |
| K081207 | Intuitive Surgical Da Vinci S Surgical System, Model IS2000, with Da Vinci Connect and…NAY · Traditional | 12/19/2008SE |
| K073112 | Da Vinci Sonicpro Cleaning System, Model 400253NVE · Traditional | 08/01/2008SE |
| K080291 | Intuitive Surgical Da Vinci Endoscopic Instruments and Control System and Endowrist…NAY · Traditional | 03/19/2008SE |
| K080155 | Modification To:Intuitive Surgical Stereo View Endoscopic SystemGCJ · Special | 03/06/2008SE |
| K072211 | Intuitive Surgical Instrument and Accessories Sterilization TraysKCT · Traditional | 02/28/2008SE |
| K070947 | Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments and Endowrist…NAY · Traditional | 02/14/2008SE |
| K072627 | Intuitive Surgical Da Vinci and Da Vinci S Surgical System and Endoscopic Instruments…NAY · Traditional | 02/07/2008SE |
| K071405 | Probe Holder SystemLKF · Traditional | 10/09/2007SE |
| K063220 | Da Vinci S Surgical SYSTEM-V1.1, Model IS2000NAY · Traditional | 12/01/2006SE |
| K061260 | Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214NAY · Special | 05/18/2006SE |
| K060391 | Intuitive Surgical Endowrist Stabilizer, Model 420182NAY · Special | 04/10/2006SE |
| K050802 | Modification to Intuitive Surgical Da Vinci Surgical System and Endoscopic InstrumentsNAY · Traditional | 06/29/2005SE |
| K050369 | Intuitive Surgical Da Vinci Surgical System, Model IS2000NAY · Traditional | 04/29/2005SE |
| K050404 | Intuitive Surgical Da Vinci Surgical System and Endoscopic InstrumentsHET · Traditional | 04/21/2005SE |
| K043288 | Modification to Intuitive Surgical Da Vinci Surgical System and Endoscopic InstrumentsNAY · Traditional | 03/03/2005SE |
| K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover Accessory, Model…NAY · Special | 01/25/2005SE |
| K043153 | Intuitive Surgical Da Vinci Surgical System and Endoscopic Instruments, Models IS1200 &…NAY · Special | 12/15/2004SE |
| K042855 | Intuitive Surgical Harmonic Curved Shears InstrumentNAY · Special | 11/12/2004SE |
| K040237 | Intuitive Surgical Da Vinci Endoscopic Instrument Control System and Endoscopic…NAY · Traditional | 07/07/2004SE |
| K040948 | Intuitive Surgical Endopass Endoscopic Delivery Instrument, Model P/N 400170NAY · Special | 05/05/2004SE |
| K022574 | Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model…NAY · Traditional | 11/12/2002SE |
| K021036 | Intuitive Surgical Da Vinci Surgical System, Model IS1000NAY · Traditional | 06/26/2002SE |
| K013952 | Intuitive Surgical Stero View Endoscopic SystemGCJ · Traditional | 02/28/2002SE |
| K013416 | Intuitive Surgical Endowrist Endoscopic Instrument FamilyGEI · Traditional | 01/10/2002SE |
| K012833 | Intuitive Surgical Bipolar ForcepsNAY · Traditional | 11/16/2001SE |
| K011281 | Intuitive Surgical Ultrasonic ShearsNAY · Traditional | 07/24/2001SE |
| K011002 | Intuitive Surgical Da Vinci Surgical System, Model Isi 1000NAY · Traditional | 05/30/2001SE |
| K002489 | Intuitive Surgical Da Vinci Endoscopic Control SystemNAY · Traditional | 03/02/2001SE |
| K001666 | Modification to Intuitive Surgical Stereo View Endoscopic SystemGCJ · Traditional | 08/24/2000SE |
| K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…NAY · Traditional | 07/11/2000SE |
| K990188 | Intuitive Surgical Stereo View Endoscopic System, Model SVS-1GCJ · Traditional | 04/01/1999SE |
| K965001 | Intuitive Surgical Monarch Laparoscopic ManipulatorGCJ · Traditional | 07/31/1997SE |
Recalls (latest 200)
| Recall | Product | Initiated |
|---|---|---|
| Z-2310-2026 Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746…Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination… | 04/24/2026Open, Classified |
| Z-2521-2026 Class II | Da Vinci ASSY, PSS, SP1098, Part Number: 380601Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a… | 04/22/2026Open, Classified |
| Z-2046-2026 Class II | Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System…Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. | 04/02/2026Open, Classified |
| Z-1855-2026 Class I | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | 03/11/2026Open, Classified |
| Z-1355-2026 Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Number:…Robotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss… | 12/30/2025Open, Classified |
| Z-1096-2026 Class II | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073…Access Port System tray may develop cracks potentially resulting in a sterility breach. | 12/15/2025Open, Classified |
| Z-1701-2026 Class II | Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S…Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | 12/09/2025Open, Classified |
| Z-1700-2026 Class II | Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si…Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | 12/09/2025Open, Classified |
| Z-1699-2026 Class II | Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si…Due to increased complaints for broken/frayed grip cables for reusable instruments. | 12/09/2025Open, Classified |
| Z-1698-2026 Class II | Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si…Due to increased complaints for broken/frayed grip cables for reusable instruments. | 12/09/2025Open, Classified |
| Z-1697-2026 Class II | Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci…Due to increased complaints for broken/frayed grip cables for reusable instruments. | 12/09/2025Open, Classified |
| Z-1696-2026 Class II | Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S…Due to increased complaints for broken/frayed grip cables for reusable instruments. | 12/09/2025Open, Classified |
| Z-1134-2026 Class II | Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog…Due to probe bags that may have a compromised or incomplete sterile pouch seal. | 12/04/2025Open, Classified |
| Z-1428-2026 Class II | Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally…An error event following the release of a software version for the surgical system that can result in loss… | 11/17/2025Open, Classified |
| Z-1232-2026 Class II | Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical…Due to a software implementation error that allowed instruments arms failing an important diagnostic test to… | 11/07/2025Open, Classified |
| Z-2722-2026 Class II | da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the… | 05/12/2025Open, Classified |
| Z-1325-2025 Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals…Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining… | 02/26/2025Open, Classified |
| Z-0924-2025 Class II | 8MM, Small Graptor REF 470318 Is a grasping retractor Instrument used with the da Vinci…Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments | 12/19/2024Open, Classified |
| Z-0923-2025 Class II | 8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical…Due to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments | 12/19/2024Open, Classified |
| Z-0883-2025 Class II | 8MM,FORCE BIPOLAR,IS4000 REF 471405Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0882-2025 Class II | 8MM,LONG BIPOLAR GRASPER,IS4000 REF 471400Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0881-2025 Class II | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0880-2025 Class II | 8MM,MEGA SUTURECUT ND,IS4000 REF 471309Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0879-2025 Class II | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 471296Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0878-2025 Class II | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 471205Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0877-2025 Class II | 8MM,COBRA GRASPER,IS4000 REF 471190Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0876-2025 Class II | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0875-2025 Class II | 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 471171Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0874-2025 Class II | 8MM,PROGRASP FORCEPS,IS4000 REF 471093Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0873-2025 Class II | 8MM,CADIERE FORCEPS,IS4000 REF 471049Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0872-2025 Class II | 8MM,LONG TIP FORCEPS,IS4000 REF 471048Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0871-2025 Class II | 8MM,FORCE BIPOLAR,IS4000 REF 470405Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0870-2025 Class II | 8MM,HORIZON SMALL CLIP APPLIER,IS4000 REF 470401Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0869-2025 Class II | 8MM,TIP-UP FENESTRATED GRASPER,IS4000 REF 470347Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0868-2025 Class II | 8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 470344Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0867-2025 Class II | 8MM,MEDIUM-LARGE CLIP APPLIER,IS4000 REF 470327Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0866-2025 Class II | 8MM,SMALL GRASPING RETRACTOR,IS4000 REF 470318Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0865-2025 Class II | 8MM,MEGA SUTURECUT ND,IS4000 REF 470309Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0864-2025 Class II | 8MM,LARGE SUTURECUT NEEDLE DRIVER,IS4000 REF 470296Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0863-2025 Class II | 8MM,DUAL BLADE RETRACTOR,IS4000 REF 470249Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0862-2025 Class II | 8MM,ATRIAL RETRACTOR SHORT RIGHT,IS4000 REF 470246Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0861-2025 Class II | 8MM,LARGE HEM-O-LOK CLIP APPLIER,IS4000 REF 470230Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0860-2025 Class II | 8MM,TENACULUM FORCEPS,IS4000 REF 470207Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0859-2025 Class II | 8MM,FENESTRATED BIPOLAR FORCEPS,IS4000 REF 470205Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0858-2025 Class II | 8MM,MEGA NEEDLE DRIVER,IS4000 REF 470194Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0857-2025 Class II | 8MM,RESANO FORCEPS,IS4000 REF 470181Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0856-2025 Class II | 8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 470172Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0855-2025 Class II | 8MM,MICRO BIPOLAR FORCEPS,IS4000 REF 470171Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0854-2025 Class II | 8MM,PROGRASP FORCEPS,IS4000 REF 470093Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0853-2025 Class II | 8MM,CADIERE FORCEPS,IS4000 REF 470049Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0852-2025 Class II | 8MM,DEBAKEY FORCEPS,IS4000 REF 470036Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0851-2025 Class II | 8MM,BLACK DIAMOND MICRO FORCEPS,IS4000 REF 470033Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0850-2025 Class II | 8MM, ROUND TIP SCISSORS, IS4000 REF 470007Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0849-2025 Class II | 8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0848-2025 Class II | 8MM, POTTS SCISSORS, IS4000 REF 470001Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0847-2025 Class II | 8MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. | 12/19/2024Open, Classified |
| Z-0964-2026 Class II | da Vinci 5, Surgeon Console Column Motor Connector; ASSY,DV5 CONSOLE,SSC,IS5000; Part…Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable… | 08/21/2024Open, Classified |
| Z-2720-2024 Class II | Ion Endoluminal System, REF: 380748-65There is a potential that the robotic system's instrument cart arm may contain screws that may potentially… | 07/12/2024Open, Classified |
| Z-1518-2024 Class II | Patient Cart, Part: 380601, a component of the da Vinci SP Surgical System, Model: SP1098Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide… | 03/13/2024Open, Classified |
| Z-0406-2024 Class II | Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mmThere is the potential for the needle drive to become dislodged and/or broken which could result in… | 10/06/2023Open, Classified |
| Z-2059-2023 Class II | da Vinci Xi/X Tip-Up Fenestrated Grasper, REF: 470347, VER: 12Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or… | 06/12/2023Open, Classified |
| Z-1293-2023 Class II | da Vinci Xi Surgical System Model IS4000 da Vinci X Surgical System Model IS4200Due to Universal Surgical Manipulator (USM) instrument carriage being loose as a result of the linear rail… | 02/10/2023Open, Classified |
| Z-1262-2023 Class II | Patient Side Cart, REF: 380620, with instrument arms, used as part of the da Vinci X…Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow… | 01/24/2023Open, Classified |
| Z-0340-2023 Class II | INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530…Potential staple deployment failure and device fragment generation | 10/07/2022Open, Classified |
| Z-0133-2023 Class II | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon…Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments… | 09/20/2022Open, Classified |
| Z-1460-2022 Class II | Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier…Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the… | 07/01/2022Open, Classified |
| Z-1459-2022 Class II | Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier…Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the… | 07/01/2022Open, Classified |
| Z-1484-2022 Class II | The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to…Due to preventative maintenance (PM) not being performed on E-100 generators which is a bipolar… | 06/22/2022Open, Classified |
| Z-0999-2022 Class II | da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45…As a result of complaint data review, it identified tissue pushout events occurring during firing of the… | 03/17/2022Open, Classified |
| Z-1210-2022 Class II | DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF…Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result… | 03/03/2022Open, Classified |
| Z-1209-2022 Class II | VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da…Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result… | 03/03/2022Open, Classified |
| Z-0702-2022 Class II | da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional… | 12/23/2021Open, Classified |
| Z-0419-2022 Class II | da Vinci SP Surgical systems with the following Model Name/ Model Number / UDI:…Issue was identified during internal engineering evaluation. Use of the system with the affected software… | 09/22/2021Open, Classified |
| Z-0275-2022 Class II | The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main…Incorrect expiration date on its package labeling (shipper box and inner carton label). | 09/21/2021Terminated |
| Z-0106-2022 Class II | Ion Flexison Biopsy Needle, 19G, Extension Range : 0-3 cm, Ref: 490104-09 and 49004-10…Potential for the sheath tip on the biopsy needle to separate from the sheath shaft. | 08/06/2021Terminated |
| Z-0489-2021 Class II | Box Label: ION Fully Articulating Catheter, REF 490105, VER 08 - Product Usage: used to…The distal tip ring of the fully articulating catheter may become dislodged during the procedure. | 10/23/2020Terminated |
| Z-2950-2020 Class II | ION Reprocessing Accessories Kit, IF1000 (Part Number: 490024-03) UDI:00886874119129.…One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or… | 06/10/2020Open, Classified |
| Z-2949-2020 Class II | Ion Catheter Reprocessing Cover, IF1000 (Part Number:490114-02) UDI:00886874116845.One type of the ION Catheter Reprocessing Covers (PN 490114-02) has the potential to become disengaged or… | 06/10/2020Open, Classified |
| Z-2329-2020 Class II | STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-03 - Product…Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays… | 12/19/2019Terminated |
| Z-2328-2020 Class II | STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02 - Product…Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope sterilization trays… | 12/19/2019Terminated |
| Z-2131-2020 Class II | da Vinci SP Camera; PN 430060-33; Model Number: 430060-33. For endoscopic surgery.Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may… | 08/19/2019Open, Classified |
| Z-0927-2020 Class II | da Vinci SP Surgical System, SP1098, 00886874114605 Product Usage: used with an…The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci… | 07/26/2019Terminated |
| Z-0926-2020 Class II | da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used…The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci… | 07/26/2019Terminated |
| Z-0925-2020 Class II | da Vinci Xi Surgical System Surgical System, IS4000, 00886874114216 - Product Usage:…The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci… | 07/26/2019Terminated |
| Z-1891-2020 Class II | daVinci XI Sureform 60 Reload, 60 mm black 6-Row 4.6 mm, Ref: 48360T-08 , UDI:…The firm became aware of a manufacturing variation in which black and green reloads in select Stapler… | 07/01/2019Open, Classified |
| Z-1890-2020 Class II | daVinci XI Sureform 60 reload, 60 mm Green 6- Row, 4.6 mm, REF 48360G-08, UDI:…The firm became aware of a manufacturing variation in which black and green reloads in select Stapler… | 07/01/2019Open, Classified |
| Z-0283-2021 Class II | da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI:…One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of… | 06/17/2019Terminated |
| Z-1897-2020 Class II | da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system…Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm… | 04/11/2019Terminated |
| Z-1896-2020 Class II | da Vinci Xi Surgical System, IS4000 - Product Usage: The da Vinci Xi surgical system…Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm… | 04/11/2019Terminated |
| Z-2260-2020 Class II | da Vinci SP surgical systemIntuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument… | 04/01/2019Terminated |
| Z-0841-2019 Class II | daVinci Harmonic ACE Curved ShearsDuring an internal inspection, Intuitive found that the sterile packaging of the da Vinci S/Si Harmonic ACE… | 01/16/2019Open, Classified |
| Z-1105-2020 Class II | Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS), model number 470179-19, UDI:…This recall is being initiated because lots of EndoWrist Monopolar Curved Scissor instruments are not… | 12/04/2018Terminated |
| Z-1961-2020 Class II | da Vinci X Surgical SystemDue to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error… | 11/21/2018Terminated |
| Z-1960-2020 Class II | da Vinci Xi Surgical SystemDue to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error… | 11/21/2018Terminated |
| Z-1906-2020 Class II | da Vinci SP Instrument Arm Drape. REF 430013-12 QTY 1 PouchThe instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier. | 10/25/2018Terminated |
| Z-0845-2020 Class II | The da Vinci SP surgical system is made of three main components: the Surgeon Console…The firm became aware of a problem with the surgical system where the cannula mount button may be damaged… | 10/23/2018Terminated |
| Z-3025-2018 Class II | da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage:…Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of… | 08/15/2018Open, Classified |
| Z-3024-2018 Class II | da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage:…Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of… | 08/15/2018Open, Classified |
| Z-3254-2018 Class II | da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The…Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side… | 07/16/2018Terminated |
| Z-0249-2020 Class II | EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory…The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator… | 06/04/2018Open, Classified |
| Z-2835-2018 Class II | The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model…An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may… | 05/17/2018Open, Classified |
| Z-2381-2018 Class II | da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue… | 04/23/2018Terminated |
| Z-2380-2018 Class II | da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue… | 04/23/2018Terminated |
| Z-2341-2018 Class II | da Vinci X Surgical System, Model IS4200. Product Usage: The Intuitive Surgical…Specific da Vinci X Surgical Systems (IS4200) were shipped with defective Arm Controller Joint (ACJ) boards… | 03/07/2018Terminated |
| Z-0404-2018 Class II | daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical…Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the… | 09/19/2017Terminated |
| Z-2630-2017 Class II | da Vinci Xi Surgical System Product Usage: The da Vinci Xi Surgical System (IS4000) is…da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially… | 06/01/2017Terminated |
| Z-1819-2017 Class II | da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and SOFTWARE…Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da Vinci Xi… | 03/31/2017Terminated |
| Z-1729-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1728-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1727-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1726-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1725-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1724-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1723-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1722-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1721-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1720-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1719-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1718-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1717-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1716-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1715-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-1714-2017 Class II | STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da…Intuitive Surgical has become aware and further investigation has determined that misinterpretation of… | 03/15/2017Terminated |
| Z-0315-2017 Class II | da Vinci Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and…Intuitive Surgical has identified a software anomaly in the da Vinci Xi P5 software that can result in… | 10/05/2016Terminated |
| Z-2677-2016 Class II | CURVED-TIP STAPLER 30,IS4000; Model number 470530; General and Plastic Surgery: The…Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30… | 07/14/2016Terminated |
| Z-2676-2016 Class II | STAPLER 30,IS4000; Model number 470430; General and Plastic Surgery: The Intuitive…Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30… | 07/14/2016Terminated |
| Z-2675-2016 Class II | STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical…Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30… | 07/14/2016Terminated |
| Z-2350-2016 Class II | CURVED-TIP STAPLER 30,IS4000, model number 470530; Gastroenterology/Urology: The…An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler… | 07/14/2016Terminated |
| Z-2349-2016 Class II | STAPLER 30, IS4000, model number 470430; Gastroenterology/Urology: The Intuitive…An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler… | 07/14/2016Terminated |
| Z-2348-2016 Class II | STAPLER 45, IS4000, model number 470298 Gastroenterology/Urology: The Intuitive Surgical…An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler… | 07/14/2016Terminated |
| Z-1837-2016 Class II | SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05…Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The… | 05/09/2016Terminated |
| Z-1836-2016 Class II | SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05…Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The… | 05/09/2016Terminated |
| Z-1568-2016 Class II | EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000)…Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating… | 03/25/2016Terminated |
| Z-1377-2016 Class II | da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The…Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large… | 03/16/2016Terminated |
| Z-1376-2016 Class II | da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual, instrument & accessory.…Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large… | 03/16/2016Terminated |
| Z-1191-2016 Class II | da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model… | 02/16/2016Terminated |
| Z-0653-2016 Class II | 30 deg, 8mm Endoscope, IS4000: Model numbers: 470027-34, 470027-40, 470027-41. General…This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm… | 11/23/2015Terminated |
| Z-0652-2016 Class II | 0 deg, 8mm Endoscope, IS4000: Model numbers: 470026-34, 470026-40, 470026-41. General…This correction to the da Vinci Xi I&A User Manual communicates proper use of the da Vinci Xi 8 mm… | 11/23/2015Terminated |
| Z-2782-2015 Class II | Fluorescence Imaging Procedure Kits used with the da Vinci Si and Xi Surgical Systems…B. Braun 2 gang 4-way stopcocks in the Fluorescence Imaging Procedure Kit may experience damage to the… | 09/09/2015Terminated |
| Z-2734-2015 Class II | da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General…Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version… | 08/17/2015Terminated |
| Z-2758-2015 Class II | Fenestrated Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2757-2015 Class II | Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers:…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2756-2015 Class II | Maryland Bipolar Forceps; used with the da Vinci Si Surgical System (IS3000); Model…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2755-2015 Class II | Crocodile Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers:…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2754-2015 Class II | Fundus Grasper; used with the da Vinci Si Surgical System (IS3000); Model numbers:…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2753-2015 Class II | Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers:…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2752-2015 Class II | Cadiere Forceps; used with the da Vinci Si Surgical System (IS3000); Model numbers:…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2751-2015 Class II | Medium -Large Clip Applier; used with the da Vinci Si Surgical System (IS3000); Model…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-2750-2015 Class II | Maryland Dissector; used with the da Vinci Si Surgical System (IS3000); Model numbers:…In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated… | 08/08/2015Terminated |
| Z-1949-2015 Class II | INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. The…Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi… | 06/16/2015Terminated |
| Z-1812-2015 Class II | Thoracic Grasper, 5 MM, for use with da Vinci S (IS2000) and SI (IS3000) Surgical…The coating of the 5 mm Thoracic Grasper main tube may experience damage with the possibility of fragments… | 05/21/2015Terminated |
| Z-1393-2015 Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1392-2015 Class II | da Vinci Si Surgical System IS3000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1391-2015 Class II | da Vinci Si Surgical System IS3000, Camera Arm Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1390-2015 Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 4 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1389-2015 Class II | da Vinci S Surgical System IS2000, Disposable Accessory Kit, 3 ARM, 5 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1388-2015 Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Camera Arm Drape, 20 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1387-2015 Class II | da Vinci S / Si Surgical System IS2000 / IS3000, Instrument Arm Drape, 20 Pack. Microtek…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1386-2015 Class II | da Vinci Si Surgical System IS3000, Monitor Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1385-2015 Class II | da Vinci Si Surgical System IS3000, Camera Head Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1384-2015 Class II | da Vinci S Surgical System IS2000, Vision-Cart Monitor Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1383-2015 Class II | da Vinci S Surgical System IS2000, Patient-Cart Monitor Drape, 20 Pack. Microtek Medical…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1382-2015 Class II | da Vinci S Surgical System IS2000, Camera Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1381-2015 Class II | da Vinci S Surgical System IS2000, Camera Arm Drape, 20 Pack. Microtek Medical Equipment…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1380-2015 Class II | da Vinci S Surgical System IS2000, Arm Drape, 20 Pack. Microtek Medical Equipment Drapes…Cloudy/waxy appearance with potential to transfer waxy substance to the patient, and potential for drape to… | 03/16/2015Terminated |
| Z-1304-2015 Class II | da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and…Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the… | 03/03/2015Terminated |
| Z-1303-2015 Class II | da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number:…Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the… | 03/03/2015Terminated |
| Z-1302-2015 Class II | da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number:…Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the… | 03/03/2015Terminated |
| Z-1226-2015 Class II | Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si…There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer… | 02/16/2015Terminated |
| Z-1142-2015 Class II | EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci…Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit… | 02/11/2015Terminated |
| Z-1141-2015 Class II | EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da Vinci…Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit… | 02/11/2015Terminated |
| Z-1118-2015 Class II | HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da…Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to… | 01/21/2015Terminated |
| Z-1117-2015 Class II | HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci…Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to… | 01/21/2015Terminated |
| Z-1048-2015 Class II | da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 System.…The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inconsistent… | 01/15/2015Terminated |
| Z-0940-2015 Class II | IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System…Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side… | 12/05/2014Terminated |
| Z-0835-2015 Class II | Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging…The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure… | 11/21/2014Terminated |
| Z-0834-2015 Class II | Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging…The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure… | 11/21/2014Terminated |
| Z-0448-2015 Class II | 8MM, TIP-UP FENESTRATED GRASPER; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0447-2015 Class II | 8MM, CURVED BIPOLAR DISSECTOR; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0446-2015 Class II | 8MM,MEDIUM-LARGE CLIP APPLIER ; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0445-2015 Class II | 8MM, SMALL GRASPING RETRACTOR ; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0444-2015 Class II | 8MM, MEGA SUTURECUT ND; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0443-2015 Class II | 8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0442-2015 Class II | 8MM, ATRIAL RETRACTOR SHORT RIGHT ; Intended to assist in the accurate control of…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0441-2015 Class II | 8MM, LARGE HEM-O-LOK CLIP APPLIER; Intended to assist in the accurate control of… | 11/03/2014Terminated |
| Z-0440-2015 Class II | 8MM, CARDIAC PROBE GRASPER; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0439-2015 Class II | 8MM, TENACULUM FORCEPS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0438-2015 Class II | 8MM FENESTRATED BIPOLAR FORCEPS,; Intended to assist in the accurate control of…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0437-2015 Class II | 8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0436-2015 Class II | 8MM PERMANENT CAUTERY HOOK,; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0435-2015 Class II | 8MM RESANO FORCEPS,; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0434-2015 Class II | 8MM MONOPOLAR CURVED SCISSORS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0433-2015 Class II | 8MM,MARYLAND BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0432-2015 Class II | 8MM,PROGRASP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0431-2015 Class II | 8MM,MICRO BIPOLAR FORCEPS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0430-2015 Class II | 8MM,LONG TIP FORCEPS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0429-2015 Class II | 8MM,BLACK DIAMOND MICRO FORCEPS; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface… | 11/03/2014Terminated |
| Z-0428-2015 Class II | 8MM,LARGE NEEDLE DRIVER; Intended to assist in the accurate control of Intuitive…Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface… | 11/03/2014Terminated |
| Z-0427-2015 Class II | 8MM,POTTS SCISSORS; Intended to assist in the accurate control of Intuitive Surgical…Deviations in reprocessing steps from those stated in the reprocessing instructions, can cause surface… | 11/03/2014Terminated |
| Z-0074-2015 Class II | EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product…Intuitive is issuing an urgent product notice to all users of the EndoWrist Stapler 45 to discontinue use… | 09/18/2014Terminated |