Events

Recall of ELECTROSURGICAL GENERATOR

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
    26976
  • Event Risk Class
    III
  • Event Initiated Date
    2017-08-14
  • 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 is taking corrective action to upgrade the software of esg-400 units after receiving complaints that certain error codes may be generated/displayed during a procedure even though the possible causes for the error codes do not exist. when the error codes are generated high frequency output from the esg-400 generator is suspended and therefore the generation of these incorrect error codees can result in a delay in the medical procedure.

Device

ELECTROSURGICAL GENERATOR
  • Model / Serial
    Model Catalog: ESG-400 (Lot serial: >100 NUMBERS CONTACT MFG.)
  • Product Description
    ELECTROSURGICAL GENERATOR
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.