The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1433-2013·Announced 2013-06-05

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

Intuitive Surgical is recalling 8mm Fenestrated Bipolar Forceps used with the da Vinci Surgical System because the cautery plug insert may dislodge, preventing proper cable connection and causing loss of cautery 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. The hazard involves the loss of cautery function in a surgical instrument, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Intuitive Surgical, Inc. is recalling 8mm Fenestrated Bipolar Forceps (Model 400205-04) used in conjunction with the da Vinci Surgical System, Model IS1200. These are multiple-use electrosurgical endoscopic instruments. The recall involves 697 units.

The recall is being conducted because reports indicate that the Cautery Plug Insert may dislodge 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.

The affected products were distributed worldwide, including nationwide in the United States and in various countries such as Austria, Australia, Belgium, Canada, and the United Kingdom. Specific lot numbers are listed in the recall documentation. Healthcare facilities and users of these instruments should stop using the affected forceps and contact Intuitive Surgical for instructions on how to proceed.

The recalled product

Product
8mm Fenestrated 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: 400205-04

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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