Events

Recall of OES PRO HF-ELECTRODES

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
    26963
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-24
  • 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 manufacturer olympus winter ibe (owi) has initiated this removal action after receiving an increased number of complaints regarding loop wires breaking at the distal end of the referenced electrodes. investigations have confirmed that loop wires can break during the intended use of the electrodes. as a result a fragment may fall inside the patient and will need to be retrieved. under certain circumstances the retrieval of this fragment could require additional surgical treatment.

Device

OES PRO HF-ELECTRODES
  • Model / Serial
    Model Catalog: WA22037C (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: A22201C (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    OLYMPUS MONOPOLAR HF RESECTION ELECTRODES
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.