Recall Z-2020-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
| Date | Jul 8, 2014 (initiated Jun 13, 2014) |
| Status | Terminated |
| Reason | Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm cannula or with certain reducer accessories.. |
| Root cause | Process control |
| Action | Urgent Medical Device Correction letters were sent on June 18, 2014 to all affected sites via trackable mail. |
| Quantity | 5290 for part 420230-04; 1964 for part 420240-06 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc., Apr 29, 2005 |