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 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
    53041
  • Event Risk Class
    II
  • Event Initiated Date
    2013-05-13
  • 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 urgical system uses a sterile adapter as the interface between the (sterile) instrument and the (non-sterile) system. for the is2000 and is3000 system models. the sterile adapter is integrated into the instrument arm drape. intuitive surgical is implementing a voluntary action to provide users of the da vinci s si and si-e systems with additional information regarding sterile adapter engagement and instrument installation.

Device

DA VINCI SI SYSTEM - MAIN
  • Model / Serial
    Model Catalog: IS3000 (Lot serial: >10 serial numbers.); Model Catalog: IS3000 (Lot serial: Contact manufacturer.); Model Catalog: IS2000 (Lot serial: SG570); Model Catalog: IS2000 (Lot serial: SG431); Model Catalog: IS2000 (Lot serial: SG359); Model Catalog: IS2000 (Lot serial: SG345); Model Catalog: IS2000 (Lot serial: SG268); Model Catalog: IS2000 (Lot serial: SG242)
  • Product Description
    Sterile Adapter for IS3000 Model
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.