Events

Recall of SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by VANTAGE ENDOSCOPY 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
    14774
  • Event Risk Class
    II
  • Event Initiated Date
    2016-03-01
  • 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
    The operation manuals containing reprocessing instructions have been updated to reflect newly validated manual cleaning and high-level disinfection procedures. given publicized reports of multi-drug resistant bacteria on certain duodenoscopes used for endoscopic retrograde cholangiopancreatogram (ercp) procedures and in an abundance of caution fujifilm has been working with the fda to validate revised reprocessing procedures that have been provided in the operation manuals. healthcare providers are being instructed to follow the exact instructions for reprocessing provided in the revised operation manuals in order to minimize the risk of disease transmission.

Device

SERIES 400 ELECTRONIC VIDEO ENDOSCOPE SYSTEM - DUODENOSCOPE
  • Model / Serial
    Model Catalog: ED-530XT (Lot serial: all)
  • Product Description
    Fujifilm Duodenoscope
  • Manufacturer
    VANTAGE ENDOSCOPY INC.

Manufacturer

VANTAGE ENDOSCOPY INC.
  • Manufacturer Address
    KITCHENER
  • Manufacturer Parent Company (2017)
    Diploma Plc
  • Source
    HC