Events

Recall of OES HYSTEROSCOPY TELESCOPES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARSEN GROUP 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
    22305
  • Event Risk Class
    II
  • Event Initiated Date
    2005-10-05
  • 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
    Units manufactured with wrong dimensional tolerance between light guide post and distal edge of telescope's main body. may cause connection between telescopes and hysteroscope sheaths to become loose during use.

Device

OES HYSTEROSCOPY TELESCOPES
  • Model / Serial
    Model Catalog: A4674A (Lot serial: QZ00843); Model Catalog: A4674A (Lot serial: (THESE ARE SERIAL NUMBERS)); Model Catalog: A4674A (Lot serial: QZ00836)
  • Product Description
    HYSTEROSCOPY TELESCOPE
  • Manufacturer
    CARSEN GROUP INC.

Manufacturer

CARSEN GROUP INC.
  • Manufacturer Address
    MARKHAM
  • Source
    HC