Recall Z-2339-2012 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at the scissor blades. The Monopolar Curved Scissors are intended for endoscopic manipulation of tissue, including: cutting, b
| Date | Sep 10, 2012 (initiated Aug 9, 2012) |
| Status | Terminated |
| Reason | There is potential for the sterility of the product to be compromised. |
| Root cause | Employee error |
| Action | Intuitive Surgical sent a "MEDICAL DEVICE CORRECTION" letter dated August 9, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. An Acknowledgement Form was included for customers to complete and return via fax to (408) 716-3040. Contact Customer Service at 1-800-876-1310 for questions regarding this recall. |
| Quantity | 11,121 Boxes |
| Distribution | Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Canada, and Lebanon |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112263 | MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY Intuitive Surgical, Inc., Oct 7, 2011 |