Rappel de Nitinol RF Reusable Electrodes

Recall

RC-2017-RN-00846-1

Class I

2017-07-11

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00846-1

The manufacturer, cosman medical, has received complaints regarding nitinol rf (model tcn) reusable electrodes. after multiple reprocessing cycles, the epoxy resin which holds the tcn electrode in the hub can exhibit signs of damage. this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilising the device. the failure to completely remove any blood and/or tissue from the tcn electrodes prior to re-sterilisation creates a potential risk of infection and spread of blood borne pathogens to patients.Cosman medical is implementing an action for nitinol rf (tcn) reusable electrodes to convert them to single patient use electrodes (re-usable for one patient only). after single patient use, the used tcn electrode should be disposed of in accordance with the individual institution’s infectious material/biohazard waste control procedures. to date, cosman have not received any reports of patient injury related to this issue.

Action to be taken by users: Cosman Medical is implementing an action for Nitinol RF (TCN) reusable electrodes to convert them to single patient use electrodes. After single patient use, the used TCN Electrode should be disposed of in accordance with the individual institution’s infectious material/biohazard waste control procedures. Unopened TCN Electrodes need to be identified as single patient use only (re-usable for one patient only). These devices are supplied non-sterile which require cleaning and sterilisation prior to use. These TCN electrodes may be used once the cleaning and sterilisation steps are completed. Isolate any used affected items. A LifeHealthcare Representative will arrange collection and replacement. Return the Reply Form provided by LifeHealthcare so they can validate that all customers have been advised of this action.