Intuitive Surgical, Inc.: 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.

Agency Publication Date: July 2, 2014

Affected Products

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

Part numbers 550120 for standard; 550516 for S system and 550650 for Si System.

Product: 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.

Part number 550675

Product: Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

Part number 550866

Product: Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

Part number 550973

Product: Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

Part number 550986

Product: Vessel Sealer Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

Part number 551027

Product: Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

Part number 551182

Product: Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System. Intuitive Surgical Endoscopic Instrument Control System.

Part number 551184 - US Manual; Part number 550965 - OUs manuals.

Product: 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.

Part number 551979 - da Vinci S, Si and SI-e Part number 551980 - da Vinci Standard.

Product: Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

Part number 551992.

Product: Connection QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

Part number 551993.

Product: Natural Rubber Latex QRG for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si System . Intuitive Surgical Endoscopic Instrument Control System.

Part number 551997.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 68472

Status: Resolved

Manufacturer: Intuitive Surgical, Inc.

Manufactured In: United States

Units Affected: 12 products (All distributed prior to June 2014)

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Sources: FDA iRES · Raw API Response

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