Recall Z-1142-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with the da Vinci Surgical System Xi IS4000. The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Xi Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels
| Date | Feb 24, 2015 (initiated Feb 11, 2015) |
| Status | Terminated |
| Reason | Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to exhibit interference in the back of the instrument grips due to manufacturing variability in some jaws. |
| Root cause | Process control |
| Action | Intuitive Surgical sent an Urgent Medical Device Correction letter dated Feruary 11, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to take the following actions: 1. Forward this letter to any members of your medical staff who perform da Vinci procedures in addition to your Risk Manager, OR Director, Purchasing and Biomedical Engineering staff. 2. This field correction does not require you to quarantine or return the affected devices. Vessel Sealers can continue to be used safely by adheri |
| Quantity | 3282 - total both part numbers |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, China, Denmark, Ecuador, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Puerto Rico, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140189 | ENDOWRIST VESSEL SEALER Intuitive Surgical, Inc., Jun 5, 2014 |