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-2015-RN-00475-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00475-1
  • 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 australia is issuing revised manual cleaning and high level disinfection procedures for the tjf-q180v duodenoscope. users are not required to return any devices to olympus.Further to olympus’ safety alert notification issued in march 2015, the manufacturer has since issued new reprocessing procedures applicable to the tjf-q180v duodenoscope. key changes in the new reprocessing procedures are:-- inclusion of a new single use brush (maj-1888), for cleaning around the forceps elevator- increase the number of raising/lowering of the forceps elevator and flushing of the elevator recess during pre-cleaning and manual cleaning.Ancillary cleaning items (single use soft brushes and a new reprocessing manual) have been sent to the relevant endoscopy units pertaining to this recall for product correction.
  • Action
    Users are asked to implement the new reprocessing procedures for the TJF-Q180V and to ensure that all personnel involved in the reprocessing are knowledgeable and thoroughly trained on the new procedures. This action has been closed-out on 13/10/2016.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd