Events

Recall of URETERO-RENO VIDEOSCOPE

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
    138682
  • Event Risk Class
    II
  • Event Initiated Date
    2016-12-22
  • 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
    There was an investigation of customer complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. to date some of these complaints are associated with tissue trauma including one complaint of perforation and two complaints of insertion tubes which were stuck inside the patient and had to be surgically removed. olympus is providing a two-page instructions for safe use to remind customers of inspection instructions in the existing operation manual and also provide pictures and instructions to assist in performing the inspection.

Device

URETERO-RENO VIDEOSCOPE
  • Model / Serial
    Model Catalog: URF-V2R (Lot serial: ALL SERIAL NUMBERS); Model Catalog: URF-V2 (Lot serial: ALL SERIAL NUMBERS)
  • Product Description
    URETERO-RENO VIDEOSCOPE
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.