The Therapeutic Goods Administration (TGA) of Australia has posted a medical device safety alert concerning ThermoGuard Plus ABC Paediatric Dual Dispersive Electrodes [Reference Number: 7-383; Lot Codes: 141010X to 20150705X], manufactured by ConMed.
The ThermoGard Dual Dispersive Electrode Pads are not compatible with some brands of electrosurgical generators using "passive" CQM (Contact Quality Monitoring) Systems. Whilst there have been no reports of injury or death, there is a possibility of a patient burn when used with a "passive" CQM Electrosurgical Generator.
The manufacturer is advising users to inspect stock and discontinue use of affected devices.
For details, please refer to the TGA website:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2016-RN-00653-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 20 May 2016