The Recall Desk
HighFDA (Devices)·Z-1377-2016·Announced 2016-04-20

Intuitive Surgical Recalls da Vinci S Surgical System User Manuals

Intuitive Surgical is recalling da Vinci S Surgical System user manuals because using non-approved instruments with ablation probes may increase microscopic metallic particulates.

What this means for you

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 the hazard involves the generation of microscopic metallic particulates during surgery, which poses a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Intuitive Surgical, Inc. is recalling the English and OUS user manuals for the da Vinci S Surgical System (Model IS4000). The recall involves 248 units of the manuals distributed worldwide, including in the United States, Australia, Canada, and various European and Asian countries.

The recall was initiated because the company found that using instruments other than the Cardiac Probe Grasper, such as the Large Needle Driver Instrument, to manipulate ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from contact with the probes. The da Vinci S Surgical System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during various surgical procedures, including urologic, general laparoscopic, gynecologic, and thoracoscopic procedures.

Healthcare facilities and users of the da Vinci S Surgical System should stop using the affected user manuals and contact Intuitive Surgical for further instructions. The recall is classified as Class II by the FDA, indicating a situation where 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.

The recalled product

Product
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments inclu
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Robotics
Hazard
Affected units
248

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 551457- IS4000 English: Model number 551706 - IS4000 OUS

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

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Same hazard · metallic particulates

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