Large 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. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.

Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.

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. Customers with questions were instructed to contact Intuitive Surgical Customer Service. Customers were asked to retain a copy of this letter and the acknowledgement form for their files. For questions regarding this recall call 800-876-1310, option 3. Japan 0120-56-5635 or 03-5575-1362 South Korea 02-3271-3200 Europe, Middle East, Asia and Africa +800 0821 2020 +41 21 821 2020 For questions regarding this recall call 408-523-2100. Urgent Medical Device Recall notification letters were sent to all affected sites on November 15, 2013.