Recall Z-0520-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Me
| Date | Dec 16, 2013 (initiated Nov 15, 2013) |
| Status | Terminated |
| Reason | Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers. |
| Root cause | Software design (manufacturing process) |
| Action | Intuitive Surgical sent a Field Safety Notice dated November 15, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to ensure all appropriate personnel are fully informed of the Notification. Discontinue use of affected product, Use the attached instructions to identify and segregate affected product. Return affected product to Intuitive Surgical following the established Returned Materials Authorization (RMA) process. Complete the Acknowledgement Form and return to Intuitive Surgical. Cus |
| Quantity | 15, 236 UPDATED 12/19/13 to 11,235 |
| Distribution | Worldwide Distribution - USA (nationwide and Puerto Rico) and Internationally to Finland, Belgium, Netherlands, UK, Czech Republic, Sweden, Germany, Austria, Switzerland, Norway, Denmark, South Korea, France, Ireland, and Slovakia. |
| FDA record | Open on fda.gov |