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
    112057
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-13
  • 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 initiated removal action of endoeye hd ii video telescope following a complaint from outside of canada and u.S of a damaged temperature sensor at the endoeye tip which caused the distal end to become abnormally hot. although no patient or user injury occurred as a result of this reported complaint excessive heating of the endoeye distal end could result in patient or user injury.

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.