Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1377-2016 — 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 including rigid endoscope

U.S. FDA — Device Enforcement · United States · 2016-03-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1377-2016
Date of alert: 2016-03-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Intuitive Surgical, Inc.
Product category: device
Product type: Devices

Reported risk: Intuitive Surgical has found that the use of instruments other than the Cardiac Probe Grasper (e.g. Large Needle Driver Instrument) to manipulate the ablation probes during cardiac surgery can result in an increase of microscopic metallic particulates generated from the contact with the probes.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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