Recall Z-0436-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S Surgical System; da Vinci SI Surgical System da Vinci Si-e Surgical System; Manufactured by Intuitive Surgical Sunnyvale, CA 94086. The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS2000/3000) is intended to assist in the accurate control of Intuitive Surgica
| Date | Dec 3, 2013 (initiated Nov 11, 2013) |
| Status | Terminated |
| Reason | Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance. |
| Root cause | Device Design |
| Action | The firm, Intuitive Surgical, sent an "Urgent Medical Device Recall" letter dated November 11, 2013 all affected customers via traceable mail. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: 1. Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to all Surgeons and OR staff who perform da Vinci surgical procedures, Risk Manager, OR Director, Purchasing, and Biomedical Engineering staff. 2. Complete the attached Acknowledgement Form and return it to Intuitive Surgical v |
| Quantity | 1,386 |
| Distribution | Worldwide Distribution: US (nationwide) and to countries of: Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Denmark, France, Germany, India, Israel, Italy, Japan, S. Korea, Luxembourg, Mexico, Monaco, Netherlands, Norway, Romania. Russian Federation, Singapore, Spain, Swede |
| FDA record | Open on fda.gov |