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Terminated

Endowrist Instrument and Accessory Manual for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

FDA Recall Z-1965-2014 · Posted 2014-07-02

Recall StatusTerminated
Product CodeNAY
Date Initiated2014-05-21
Date Terminated2015-05-05
Product QuantityAll distributed prior to June 2014

Reason for Recall

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.

Firm 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 User Manuals, IFUs, and QRGs for which you have received updated versions. 4. Discard all versions of the Emergency Grip Release Wrench (Part Number 710142). Order additional IRKs from Intuitive Surgical as needed. 5. Complete and return the attached Acknowledgement Form to acknowledge that you have received the updated Labeling, IRKs, in-service and have discarded all previous versions of Labeling and the emergency grip release wrench. Please return the completed Acknowledgment Form within two days of the in-service. 6. Retain a copy of this Notice and the Acknowledgement Form for your records. If you need further information or support concerning this recall, please contact your Intuitive Surgical Representative or Intuitive Surgical Customer Service at the numbers listed below: North America: 800-876-1310 Option 3 (6 am to 5pm PST) For questions regarding this recall call 408-523-2602.

Root Cause

Device Design

Distribution Pattern

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, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Monaco, Netherlands, New Zealand, Norway, Pakistan, Philippines, Indonesia, Portugal, Puerto Rico, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovak Republic, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Uruguay, Venezuela, and Vietnam.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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