Recall Z-2930-2011 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Intuitive Surgical da Vinci Si Surgical System (IS3000); Mfg by: Intuitive Surgical, Sunnyvale, CA 94086 Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use for trained physicians in a
| Date | Aug 3, 2011 (initiated Jul 5, 2011) |
| Status | Terminated |
| Reason | Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement. |
| Root cause | Device Design |
| Action | Intuitive Surgical sent an "URGENT- MEDICAL DEVICE CORRECTION" letter dated July 1, 2011 to all affected customers. Customers were asked to complete the attached response form and return as per the instructions. The letter identifies the product, problem, and actions to be taken by the customers. The letter reinforce to customers to follow the product labeling WARNING. The letter states that all affected customers sites will be receiving a call from a Customer Support staff to schedule a retrofit of the component. A letter was also sent to non affected customers to inform them of the urgent |
| Quantity | 183 |
| Distribution | Worldwide Distribution -- USA (nationwide) and the countries of: Belgium, Czech Republic, Denmark, France, Germany, Greece, India, Ireland, Israel, Italy, Netherlands, Norway, Philippines, Portugal, Saudi Arabia, Singapore, South Korea, Spain, Switzerland, Turkey and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090993 | INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 Intuitive Surgical, Inc., Dec 16, 2009 |