Events

Recall of DA VINCI SI SYSTEM - MAIN

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTUITIVE SURGICAL INC..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    134749
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-25
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Intuitive surgical is initiating a voluntary correction regarding the use of certain da vinci endowrist instruments with a cardiac cryoablation probe. intuitive surgical has determined that microscopic metallic particulate can be generated during both robotic and non-robotic intra-cardiac surgery. the use of da vinci instruments other than the cardiac probe grasper (e.G. large needle driver) to manipulate a cardiac cryoablation probe during da vinci cardiac surgery has been shown to increase the amount of microscopic metallic particulate.

Device

DA VINCI SI SYSTEM - MAIN
  • Model / Serial
    Model Catalog: 550675 (Lot serial: ALL)
  • Product Description
    DA VINCI SI SURGICAL SYSTEM IS3000
  • Manufacturer
    INTUITIVE SURGICAL INC.

Manufacturer

INTUITIVE SURGICAL INC.