Events

Recall of EVIS EXERA VIDEO SYSTEM - DUODENOVIDEOSCOPES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by OLYMPUS CANADA 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
    26960
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-16
  • 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
    Manufacturer is issuing validated new reprocessing instructions for the olympus tjf-160f /vf duodenoscopes ("tjf-160f /vf") consisting of revised manual cleaning and high level disinfection procedures. these new reprocessing procedures should be implemented as soon as possible. the new cleaning procedure requires the use of a new cleaning brush (maj-1534). in addition to the new cleaning brush referenced above the new tjf-160f /vf reprocessing procedures require additional flushing and forceps elevator raising/lowering steps during precleaning and manual cleaning manual disinfection endoscope rinsing and alcohol flushing.

Device

EVIS EXERA VIDEO SYSTEM - DUODENOVIDEOSCOPES
  • Model / Serial
    Model Catalog: TJF-160VF (Lot serial: All lots); Model Catalog: TJF-160F (Lot serial: All lots)
  • Product Description
    EVIS EXERA VIDEO SYSTEM - DUODENOVIDEOSCOPES
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.