Events

Recall of TJF-Q180V Duodenoscope

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-2016-RN-00098-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-01-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00098-1
  • 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 received reports of patient infections associated with the elevator sealing mechanism of the tjf-q180v duodenoscope. olympus is updating the existing tjf-q180v operation manual, the tjf-q180v reprocessing manual and will perform a correction to the forceps elevator mechanism. this is further to the urgent recall for product correction notification issued in june 2015 (tga ref: rc-2015-rn-00475-1).
  • Action
    Affected units can continued to be used, provided the leakage test as outlined in the revised Reprocessing Manual is performed before every use. Olympus is providing instructions for users to access the updated Operation and Reprocessing Manual. Olympus is undertaking a correction of all affected TFJ-Q180V elevator mechanisms and will provide users with loan units whilst the units are being repaired. This action has been closed-out on 27/02/2017.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd