Recall Z-1972-2014 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System and Si-e. Intuitive Surgical Endoscopic Instrument Control System.
| Date | Jul 2, 2014 (initiated May 21, 2014) |
| Status | Terminated |
| Reason | Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK) for use with the da Vinci Surgical System, instruments and accessories. Removal of the Emergency Grip Release Wrench, part number 710142. |
| Root cause | Device Design |
| Action | Intuitive Surgical sent a Field Safety Notice dated June 16, 2014, to all consignees affected by changes in labeling, IFU User manuals and QRG's. Consignees were instructed to take the following actions: Ensure all appropriate personnel are fully informed of this Notification. Forward this letter to your Risk Manager, OR Director, Purchasing Manager, Biomedical Engineering staff and members of your medical staff who perform da Vinci surgery procedures. 2. Use Attachment C to identify the labeling that has been updated. 3. No manuals or products should be returned. Discard old versions of the U |
| Quantity | All distributed prior to June 2014 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Great Britain, Greece, Guadeloupe, India, Indonesia, Irelan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021036 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 Intuitive Surgical, Inc., Jun 26, 2002 |
| K050369 | INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 Intuitive Surgical, Inc., Apr 29, 2005 |
| K081137 | INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 Intuitive Surgical, Inc., Feb 18, 2009 |