Events

Recall of GF-UCT180 Ultrasonic Gastrovideoscope

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-00909-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-09-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00909-1
  • 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 nature of this product correction is to issue a revised instruction for use (ifu) which includes instructions on how to correctly clean the device. there is a risk of patient-to-patient infection if the device is not cleaned appropriately. key changes in the new instruction for use are highlighted below:· inclusion of instruction on how to attach the cleaning adapter (maj-350) to the instrument channel port of the gf-uct180· the balloon applicator (maj-675) and the cleaning brush (maj-1534) are to be reprocessed for reuse. the maj-675 and maj-1534 are to be reprocessed in accordance with step “cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment”.
  • Action
    Olympus is advising their customers of the amendments to the IFU. Customers can request a new IFU by contacting Olympus. Hospitals are advised that a review of internal hospital protocols should be conducted to ensure compliance with the updated cleaning instructions. This action has been closed-out on 29/08/2016.

Device

GF-UCT180 Ultrasonic Gastrovideoscope

Manufacturer

Olympus Australia Pty Ltd