Recall Z-1210-2022 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Intuitive Surgical, Inc.
DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi', Single Use Instrument 8mm, REF 480440
| Date | Mar 3, 2022 |
| Status | Completed |
| Reason | Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal. |
| Root cause | Use error |
| Action | On 03/03/22, a Field Safety Notice was sent via courier service to customers. In section 4, "Actions to be taken by the Customer/User" of the Field Safety Notice includes the following: Place the customer communication with the User Manual. In addition, 1. Read and understand the contents of the letter. 2. Notify all surgeons and personnel using the System that they should reacquaint themselves by a. Reading the instructions, warnings, and cautions provided in the Instruments and Accessories User Manual Addendum /User Manual b. Contacting Sales Representatives for clarification of queri |
| Quantity | 7,995 boxes (or 47,972 individual units ; 6 instruments/box)* The total amount will continue to grow until updated user |
| Distribution | Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Leb |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191280 | E-100 Electrosurgical Generator, SynchroSeal Intuitive Surgical, Inc., Nov 14, 2019 |