Recall Z-1377-2016 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endosco
| Date | Mar 16, 2016 |
| Status | Terminated |
| Reason | Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes. |
| Root cause | Device Design |
| Action | Intuitive sent a Field Safety Notice/Urgent Medical Device Correction letters dated March 22, 2016 by trackable mail method to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. In addition to existing instructions for use, observe the following warning when manipulating the cardiac ablation probe, Use only the Cardiac Probe Grasper to manipulate a cardiac ablation probe. 2. Distribute a copy of this letter to all da Vinci S, Si, and Xi users at your facility. 3. Place a copy of this letter with your user manual. 4. |
| Quantity | 248 - total all models |
| Distribution | Worldwide Distribution - US Nationwide in the countries Australia, Belgium, Brazil, Canada, Chile, Finland, France, Germany, Greece, Iceland, India, Israel, Italy, Netherlands, Qatar, Russia, Singapore, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, and United Kingdom. |
| FDA record | Open on fda.gov |