Recall Z-0660-2007 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
8mm EndoWrist Bipolar Maryland Instrument, Part Number: 400172-04, Distributed and Manufactured by Intuitive Surgical, Inc. 950 Kifer Road Sunnyvale, CA
| Date | Mar 28, 2007 (initiated Mar 24, 2005) |
| Status | Terminated |
| Reason | The products were incorrectly programmed as training instruments, which allows for 30 uses (surgical procedures) instead of 10 uses. |
| Root cause | Other |
| Action | The firm initiated its recall in March 24, 2005, when the firm sent a letter via Federal Express mail to all 18 consignees, informing them of the issue, how to identify affected product, and instructions to return the affected instruments for a full credit. The form included a reply form that consignees were requested to fill out and return. |
| Quantity | 8 |
| Distribution | Product was distributed to 12 consignees in the US, who received 19 instruments, in FL, IN, LA, MN, NC, NH, NJ, NY, TN and TX. In addition, 5 consignees outside the US received product as well, in Italy, Sweden, France, Singapore and Germany. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012833 | INTUITIVE SURGICAL BIPOLAR FORCEPS Intuitive Surgical, Inc., Nov 16, 2001 |