Recall Z-1348-2008 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments. Product is distributed by Intuitive Surgical, Inc., Sunnyvale, CA
| Date | Aug 6, 2008 (initiated Jan 4, 2008) |
| Status | Terminated |
| Reason | (1) Incorrect dimension on Luer on smoke evacuation cannulae not allowing for secure attachment function. (2) Incorrect labeling. External labeling lot number differs from lot number etched on the cannula. |
| Root cause | Process control |
| Action | On 1/4/08, the firm initiated the recall and its notification was via Urgent Device Recall letters explaining the reason for the recall, requesting immediate discontinued use, segregate non-conforming product in a secure area, and a Customer Service Rep will make contact in order to arrange for the retrieval of the material. |
| Quantity | 39 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.