Events

Recall of THERMOGUARD DISPERSIVE ELECTRODE

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CONMED CANADA.

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
    38741
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-19
  • 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
    A version of the conmed thermogard dual dispersive electrodes manufactured between october 1 2014 and july 5 2015 may not be compatible with some electrosurgical generators placing patients at risk for undetected pad lift and a potential burn. a customer alerted conmed of this condition on april 6 2016. these generators use a cqm (contact quality monitoring) technology which may rely on a preset upper limit (alarm limit) of the cqm impedance to detect pad lift. please contact conmed for a complete list of compatible cqm electrosurgical generators (esu's).

Device

THERMOGUARD DISPERSIVE ELECTRODE
  • Model / Serial
    Model Catalog: 51-7310 (Lot serial: > 10 contact manufacturer); Model Catalog: 7-382 (Lot serial: > 10 contact manufacturer)
  • Product Description
    THERMOGUARD DISPERSIVE ELECTRODE
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC