Recall Z-1949-2015 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. 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.
| Date | Jul 1, 2015 (initiated Jun 16, 2015) |
| Status | Terminated |
| Reason | Field Safety Notification to advise of an issue that may occur involving the combination of the da Vinci Xi Drapes and Xi instruments. A pinched drape may cause a message on the Vision Cart touchscreen - Missing reload error. |
| Root cause | Device Design |
| Action | Intuitive Surgical sent an Urgent Medical Device Notification letter on June 16 , 2015 to all affected consignees. Consignees were instructed to take the following actions: 1. Ensure that all affected personnel are fully informed of this notice. Forward this notice to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci Surgery procedures. 2. Complete and return the attached Acknowledgment Form to Intuitive Surgical using the instructions provided. 3. Please retain a copy of this notice with your system. 4. Re |
| Quantity | 310 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131861 | DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES Intuitive Surgical, Inc., Mar 28, 2014 |