Recall Z-2757-2015
Intuitive Surgical, Inc. · initiated August 8, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Curved Needle Driver; used with the da Vinci Si Surgical System (IS3000); Model numbers: 428088-12, 428088-13. The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
Codes / lots: Model numbers: 428088-12, 428088-13; all lots
Reason for recall
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
FDA-determined cause: Device Design
Action taken
Intuitive Surgical sent an Urgent Device Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures. 2. Replace any instrument that shows signs of damage and contact Intuitive Surgical Customer Service. 3. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 4. Please retain a copy of this notice as well as the attached instructions with your Single-Site User Manual. If you need further information or support concerning this issue, please contact your Clinical Sales Representative or contact Intuitive Surgical Customer Service at the numbers listed below: North and South America: (800) 876-1310, Option 3 (6 AM to 5 PM PST) or mail: customersupport-servicesupport@intusurg.com Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or ics@intusurg.com South Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) Japan: 0120-56-5635 or 003-5575-1362 (9 AM to 6 PM JST) For questions regarding this recall call 408-523-2100.
Details
- Recall number
- Z-2757-2015
- Initiated
- August 8, 2015
- Posted by FDA
- September 10, 2015
- Terminated
- December 3, 2015
- Product code
- NAY – System, Surgical, Computer Controlled Instrument
- Quantity
- 3698 total units
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
- Recalling firm
- Intuitive Surgical, Inc., Sunnyvale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| 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-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-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-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-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-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-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-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 |