Events

Recall of Pentax ED-3490TK Video Duodenoscope

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Hoya Lens 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-00238-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-04-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00238-1
  • 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
    Pentax is issuing updated, validated manual reprocessing instructions for the ed-3490tk video duodenoscope to replace those provided in the original device labelling. the updated reprocessing instructions for the ed-3490tk video duodenoscope include a more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilisation procedures. in addition, updated instructions include additional text, figures, cautions and warnings intended to clarify the validated reprocessing procedure.If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection.
  • Action
    Pentax is providing affected customers with updated Instructions for Use intended to clarify the validated reprocessing procedure. This action has been closed-out on 27/01/2017.

Device

Pentax ED-3490TK Video Duodenoscope

Manufacturer

Hoya Lens Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    DHTGA