Events

Recall of DA VINCI S SURGICAL SYSTEM - CONTROL FOR ENDOSCOPIC INSTRUMENTS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MINOGUE MEDICAL 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
    22053
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-08
  • 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
    Voluntary action to provide users with additional information regarding sterile adapter engagement and instrument installation. although rare sterile adapter and instrument engagement issues may lead to non-intuitive motion or a sluggish response when controlling instruments. these characteristics are apparent prior to interaction with tissue and thus do not pose a risk to health or safety of patients or users.

Device

DA VINCI S SURGICAL SYSTEM - CONTROL FOR ENDOSCOPIC INSTRUMENTS
  • Model / Serial
    Model Catalog: IS2000 (Lot serial: N/A); Model Catalog: IS2000 (Lot serial: na); Model Catalog: IS3000 (Lot serial: na); Model Catalog: IS3000 (Lot serial: N/A)
  • Product Description
    DA VINCI S SURGICAL SYSTEM - CONTROL FOR ENDOSCOP
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.