Recall Z-1463-2013 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci 5 mm Instrument Cannulae for use with the da Vinci S and Si Surgical Systems. Used to establish a port of entry for Intuitive Surgical EndoWrist instruments,
| Date | Jun 5, 2013 (initiated May 6, 2013) |
| Status | Terminated |
| Reason | Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262). |
| Root cause | Use error |
| Action | Intuitive Surgical sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 14, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice. |
| Quantity | 2101 consignees |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom. |
| FDA record | Open on fda.gov |