Recall Z-1442-2013 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
| Date | May 31, 2013 (initiated May 8, 2013) |
| Status | Terminated |
| Reason | Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors version 09 and 10 instruments to develop very small cracks near the distal end. This may create a pathway for electrosurgical energy to leak to tissue and potentially cause thermal injury. |
| Root cause | Nonconforming Material/Component |
| Action | Intuitive Surgical sent an Urgent Medical Device Recall letter dated May16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised that they did not need to quarantine or return the affected device at that time. a Intuitive Surgical representative would contact them to arrange for replacement of the affected product once they became available. In the interim customers were instructed to follow the precautions and warnings outlined in Attachment A in the letter as well as the Instructions for Use. |
| Quantity | ~132,441 instruments |
| Distribution | Worldwide distribution - USA (nationwide) Foreign Distribution to Argentina, Austria, Australia, Belgium, Brazil, Bulgaria, Canada, China, Chile, Czech Republic, Denmark, Finland, France, Germany, Cyprus- Greece, Egypt, Guadeloupe, Israel, Ireland, India, Indonesia, Italy, Japan, Kuwait, Lebanon, M |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050005 | INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179; TIP COVER ACCESSORY, MODEL 400180 Intuitive Surgical, Inc., Jan 25, 2005 |