Events

Recall of Monopolar HF Resection Electrodes

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-2017-RN-00498-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-04-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00498-1
  • 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 has received an increased number of complaints regarding loop wires breaking at the distal end of the electrodes. investigations have confirmed that loop wires can break during the intended use of the electrodes. as a result, a fragment may fall inside the patient and will need to be retrieved. under certain circumstances, the retrieval could require additional surgical treatment. to date, no reports of adverse events or patient injuries have been received by olympus.
  • Action
    Olympus is requesting users to inspect their inventory and quarantine the affected lots. Affected products are to be returned for replacement.

Device

Monopolar HF Resection Electrodes
  • Model / Serial
    Monopolar HF Resection ElectrodesModel Number: A22201CLot Numbers: 16123P03L001, 16139P03L001, 16144P03L001, 16173P03L001, 16174P03L001, 16210P03L001, P16X0001, P16X0002, P16Y0001 and P16Y0003Model Number: WA22037CLot Number: P16Y0001ARTG Number: 218223
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd