The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1431-2013·Announced 2013-06-05

Intuitive Surgical Recalls 8mm Precise Bipolar Forceps Due to Cautery Plug Defect

Intuitive Surgical is recalling 8mm Precise Bipolar Forceps used with the da Vinci Surgical System because a component may dislodge, preventing proper cautery connection and causing loss of function.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (loss of surgical function) where specific injury or illness has not been reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Intuitive Surgical, Inc. is recalling 8mm Precise Bipolar Forceps (Model 400110-10) used in conjunction with the da Vinci Surgical System, Model IS1200. These are multiple-use electrosurgical endoscopic instruments. The recall involves 697 units distributed nationwide in the United States and in various countries worldwide, including Austria, Australia, Belgium, Canada, and the United Kingdom.

The recall is due to reports of the Cautery Plug Insert dislodging from the Cautery Plug Riser. This defect prevents a bipolar cautery cable from being properly connected, which results in the loss of cautery function for the Bipolar Instruments. Specific lot numbers affected include M10120807, M10120817, M10120831, M10120910, M10121008, M10121012, M10121024, M10121115, M10121123, M10121130, M10121206, M10121210, M10130124, M10130131, M10130205, M10130304, M10130319, and M10130321.

Healthcare facilities and users of these instruments should stop using the affected forceps and contact Intuitive Surgical, Inc. for further instructions on how to return or replace the devices. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recalled product

Product
8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical System, Model IS1200. Multiple use electrosurgical endoscopic instruments.
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
697

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)

  • Model number: 400110-10

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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