Events

Recall of VIDEO TELESCOPE

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
    130043
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-22
  • 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
    Olympus has initiated this recall after discovering that the endoeye distal end can become abnormally hot if the temperature sensor at the device's tip is damaged. although no customer complaints have been received referring to this issue and thus manufacturer is not aware of any patient or user injury excessive heating of the endoeye distal end could result in patient or user injury. to prevent a potential risk to patient or user health olympus is undertaking this action to repair the devices by disabling a specific feature on the video telescopes ("fog-free function") to prevent excessive heating of the endoeye distal end under certain conditions.

Device

VIDEO TELESCOPE
  • Model / Serial
    Model Catalog: WA50042A (Lot serial: >10 lot numbers contact mfg); Model Catalog: WA50040A (Lot serial: >10 lot numbers contact mfg)
  • Product Description
    VIDEO TELESCOPE
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.