The Recall Desk
ModerateFDA (Devices)·Z-1970-2014·Announced 2014-07-09

Intuitive Surgical Recalls Vessel Sealer QRG for da Vinci Systems

Intuitive Surgical is recalling Vessel Sealer QRGs for da Vinci systems to remove the Emergency Grip Release Wrench from documentation.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity where the hazard is unlikely to cause serious injury but may cause temporary adverse health consequences.

Plain-English summary

Intuitive Surgical, Inc. is recalling Vessel Sealer QRGs for the da Vinci Standard, S, and Si Surgical Systems. The recall involves the removal of the Emergency Grip Release Wrench, part number 710142, from the User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and Instrument Release Kits (IRK).

The affected products were distributed worldwide, including in the United States and numerous international locations, prior to June 2014. The specific part number for the recalled Vessel Sealer QRG is 551182.

This action is a Class II recall, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible adverse health consequences. Users should refer to the updated documentation provided by the manufacturer to ensure the Emergency Grip Release Wrench is no longer included in the relevant kits and manuals.

The recalled product

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.
Affected units
2,014

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part number 551182

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →