Recall Z-0063-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si Surgical System and the ERBE VIO 300 D electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in
| Date | Oct 10, 2014 (initiated Sep 17, 2014) |
| Status | Terminated |
| Reason | Intuitive Surgical is initiating a voluntary correction relating to the labeling and software associated with the EndoWrist. One Vessel Sealer for the da Vinci Si (IS3000) Surgical System. |
| Root cause | Device Design |
| Action | Urgent medical device correction letter was sent to all consignees on 9/22/14 by trackable mail system. Letters identified the issue and provides information for users should a error code be displayed. |
| Quantity | 1,483 devices |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Belgium, China, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130266 | ENDOWRIST ONE VESSEL SEALER Intuitive Surgical, Inc., Aug 29, 2013 |