Recall Z-0133-2023 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS)
| Date | Oct 25, 2022 (initiated Sep 20, 2022) |
| Status | Open, Classified |
| Reason | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery |
| Root cause | Software Design Change |
| Action | On 09/20/22, correction notices were mailed to customers. Customers were advised of the following: 1) The system software version can be located on the Vision Cart Touchscreen in the Troubleshooting Tab. 2) Ensure all device users read and understand this notice. 3) Notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4) Ensure proper instrument connections to the generator(s) and continue to follow all existing warnings and cautions found in user manuals 551400-15, USER MANUAL |
| Quantity | 162 |
| Distribution | US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC |
| FDA record | Open on fda.gov |