Events

Recall of HF-Resection Electrode

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Olympus Australia 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-2018-RN-00470-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-06-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00470-1
  • 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, olympus winter & ibe (owi) became aware of complaints relating to signs of wear on the handle after sterilization using the sterrad and steris, ‘casp low temperature plasma sterilizer’. during their investigation, the manufacturer confirmed that these signs of wear (slight changes in colour and structure) at the handle had occured after the first time of sterilization. whilst the sterilisation has no impact on the electrical safety of the electrodes, it no longer meets the manufacturer’s material compatibility acceptance criteria when using the sterrad and steris sterilisation methods. to ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the sterrad and steris sterilisation methods, as such the ifu has been updated to change the compatibility to “incompatible” for the reprocessing methods sterrad and steris.
  • Action
    Olympus is advising: "To ensure the intended life expectancy of the device, the manufacturer deems the material as no longer compatible when using the STERRAD and STERIS sterilisation methods, as such the IFU has been updated to change the compatibility to “incompatible” for the reprocessing methods STERRAD and STERIS". Users should inspect inventory for affected product and visually inspect the device prior to use as outlined in the IFU (section 5.1). If users are reprocessing devices using the STERRAD or STERIS, please discontinue and change to using one of the compatible reprocessing methods. An updated IFU to reflect this will be provided to users.

Device

HF-Resection Electrode
  • Model / Serial
    HF-Resection ElectrodeItem Numbers: A6280, A6281, A6282, A6283, A6284, A6289, A6292, A6293, A6294, A6299ARTG Number: 146187(Olympus Australia - Electrosurgical system, general-purpose)
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd