Events

Recall of HF-Resection Electrodes Monopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope IFU version: W7074650_03

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-00863-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-07-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00863-1
  • 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
    Olympus has updated the instructions for use (ifu) for the hf resection electrodes. the ifu has been updated to include new contraindications, warnings and safety information.
  • Action
    Olympus is asking customers to: 1. Inspect inventory and replace any existing IFUs supplied with the device as per the list on Appendix A with the latest version provided in the customer letter; 2. Ensure all personnel are trained and/or familiarised themselves with the added contraindications, warnings and safety information as stated. Do not hesitate to contact your local Olympus Sales Specialist to organise additional training; 3. Complete the supplied reply form as per the instructions given; 4. If you have distributed or transferred any of the affected items from your facility to another, please forward this recall notice and also please notify Olympus so that we can follow up with that facility directly; 5. If you require additional hard/electronic copies of the IFU, please email RA@Olympus.com.au; and 6. If you have any queries or concerns in relation to this matter please do not hesitate to contact Olympus Customer Operations on 1300 657 699 or email RA@Olympus.com.au.

Device

HF-Resection Electrodes Monopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope I...
  • Model / Serial
    HF-Resection ElectrodesMonopolar Resectoscope IFU version: W7089250_02TURis/TCRis Resectoscope IFU version: W7074650_03Multiple Item NumbersARTG Numbers: 146187 and 218223
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd