Events

Recall of ESG-100 - ELECTROSURGICAL UNIT

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
    26966
  • Event Risk Class
    II
  • Event Initiated Date
    2011-12-01
  • 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 canada inc. (oci) has initiated this recall following complaints received outside of canada associated with inconsistent or failed electrical output from the esg-100. investigation of the customer complaints has revealed two capacitors mounted on the main board of certain esg-100 may be counterfeit components. performance testing on esg-100s with counterfeit capacitors satisfied the established release specifications for this product but the performance of the counterfeit capacitors can degrade over time.

Device

ESG-100 - ELECTROSURGICAL UNIT
  • Model / Serial
    Model Catalog: ESG-100 (Lot serial: 25456W23-106); Model Catalog: ESG-100 (Lot serial: 26917W23-104); Model Catalog: ESG-100 (Lot serial: 26879W23-101); Model Catalog: ESG-100 (Lot serial: 25607W23-109); Model Catalog: ESG-100 (Lot serial: 25456W23-104); Model Catalog: ESG-100 (Lot serial: 25456W23-110); Model Catalog: ESG-100 (Lot serial: 25456W23-103); Model Catalog: ESG-100 (Lot serial: 25456W23-105); Model Catalog: ESG-100 (Lot serial: 25565W23-101)
  • Product Description
    Electrosurgical Unit
  • Manufacturer
    OLYMPUS CANADA INC.

Manufacturer

OLYMPUS CANADA INC.