Events

Recall of Nitinol RF Reusable Electrodes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Life Healthcare Pty Ltd.

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
    RC-2017-RN-00846-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00846-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    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
    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.

Device

Nitinol RF Reusable Electrodes
  • Model / Serial
    Nitinol RF Reusable ElectrodesProduct Codes: TCN-5, TCN-5-3M, TCN-10, TCN-10-3M, TCN-15, TCN-15-3M, TCN-20, TCN-20-3M, TCNK-5, TCNK-5-C, TCNK-5-R, TCNK-10, TCNK-10-C, TCNK-10-R, TCNK-15, TCNK-15-C, TCNK-15-R, TCNK-20, TCNK-20-C, TCNK-20-RAll Lot NumbersARTG Number: 158235
  • Product Classification
    Neurological Devices
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd