Events

Recall of DA VINCI SURGICAL SYSTEM (MODEL IS1000)

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
    33058
  • Event Risk Class
    II
  • Event Initiated Date
    2013-08-12
  • 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
    A revised instructions for use (ifu) for reprocessing of da vinci endowrist instruments will be released. these changes have been implemented to ensure customers have clear information related to the use and reprocessing of da vinci instruments and accessories and to assist da vinci customers with compliance to local requirements. the current ifu is still valid. this update improves the process improves the clarity of the instructions themselves and allows for alkaline cleaners and is not being performed for safety issues or the ifu is defective.

Device

DA VINCI SURGICAL SYSTEM (MODEL IS1000)
  • Model / Serial
    Model Catalog: IS1200 (Lot serial: S00173); Model Catalog: IS1200 (Lot serial: S00150); Model Catalog: IS1200 (Lot serial: S00305); Model Catalog: IS3000 (Lot serial: >10 serial numbers.); Model Catalog: IS3000 (Lot serial: Contact manufacturer.); Model Catalog: IS1200 (Lot serial: S00421); Model Catalog: IS2000 (Lot serial: SG345); Model Catalog: IS2000 (Lot serial: SG242); Model Catalog: IS2000 (Lot serial: SG268); Model Catalog: IS2000 (Lot serial: SG570); Model Catalog: IS2000 (Lot serial: SG431); Model Catalog: IS2000 (Lot serial: SG359)
  • Product Description
    Da Vinci Surgical System (Model IS1000)
  • Manufacturer
    MINOGUE MEDICAL INC.

Manufacturer

MINOGUE MEDICAL INC.