Recall Z-0876-2025
Intuitive Surgical, Inc. · initiated December 19, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 REF 471172
Codes / lots: Model Number: 471172 Part Number: 471172-16 UDI-DI code: 00886874119792 Batch Numbers: K10230831 K11230831 K12230831 K16240508 K17240508 K18240508 Model Number: 471172 Part Number: 471172-17 UDI-DI code: 00886874119792 Batch Numbers: K10221030 K10221122 K10221128 K10221212 K10221218 K10230103 K10230122 K10230129 K10230201 K10230205 K10230212 K10230219 K10230226 K10230302 K10230427 K10230504 K10230510 K10230515 K10230518 K10230526 K10230601 K10230608 K10230615 K10230622 K10230629 K10230706 K10230713 K10230714 K10230720 K10230727 K10230803 K10230810 K10230817 K10230824 K10230907 K10230914 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231123 K10231201 K10231213 K10231214 K10231218 K10240104 K10240111 K10240118 K10240120 K10240125 K10240201 K10240208 K10240215 K10240229 K10240314 K10240327 K10240404 K10240410 K10240418 K10240425 K10240502 K10240515 K10240516 K10240523 K10240530 K10240603 K10240606 K10240613 K10240618 K10240702 K10240703 K10240708 K11221030 K11221212 K11221218 K11230122 K11230205 K11230302 K11230310 K11230504 K11230515 K11230518 K11230526 K11230601 K11230608 K11230615 K11230622 K11230629 K11230706 K11230713 K11230727 K11230803 K11230810 K11230817…
Reason for recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
FDA-determined cause: Process change control
Action taken
On 12/19/2024, the firm send via email an "Urgent: Medical Device Correction" Letter informing customer that Intuitive Surgical has become aware of an increase in complaints regarding frayed or broken cables on some da Vinci X and Xi reusable instruments. Customer are instructed to: 1. Customers can continue using the products in accordance with the user manual. 2. As a reminder, when using da Vinci X and Xi reusable instruments, follow the Inspection Before Use and Warnings listed in the manual provided with your system to inspect for any broken cables. Refer to Figures C and D for examples. In addition, please refer to Appendix B for additional images for detection of grip cable failures. 3. If you observe any failed (frayed or broken) grip cables prior to use, during procedure, or during reprocessing, please stop use of instrument, remove from use and inform Intuitive via the standard complaint process. 4. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject device via the standard complaint process. For Question and assistance - " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
Details
- Recall number
- Z-0876-2025
- Initiated
- December 19, 2024
- Posted by FDA
- January 10, 2025
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 68,458
- Distribution
- U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio…
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |