Events

Recall of OER-AW Endoscope Reprocessor

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-00130-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2017-01-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00130-1
  • 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
    There is an update of the operation manual for the oer-aw endoscope reprocessor to instruct users of non-detachable distal cover type duodenoscopes, such as the tjf-q180v duodenoscope, to follow the pre-cleaning and manual cleaning as stated in the duodenoscope’s reprocessing manual prior to setting them into the oer-aw.The following warning has been added to the list of compatible endoscopes/connecting tubes and chapter 4 “basic endoscope reprocessing operations” of the oer-aw operation manual - "when reprocessing the following non-detachable distal cover type duodenoscopes using oer-aw, conduct pre-cleaning and manual cleaning as detailed in each duodenoscope’s reprocessing manual".
  • Action
    Olympus is requesting users to inspect their inventory and replace any existing OER-AW Operation Manuals and List of Compatible Endoscopes/Connecting Tubes with the latest version supplied.They are further advised to implement the instructions enclosed in the updated OER-AW Operation Manual. This action has been closed-out on 06/07/2017.

Device

OER-AW Endoscope Reprocessor
  • Model / Serial
    OER-AW Endoscope ReprocessorImpacted models of duodenoscopes: JF-20, JF-140F, TJF-M20, TJF-30, TJF-145, TJF-140F, TJF-150, TJF-160F, TJF-160VF and TJF-Q180VARTG Number: 185051
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd