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 Pentax Medical Pte 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-00120-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-10-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00120-1
  • 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 medical is informing customers about a potential issue associated with the distal cap of the ed-3490tk and offer recommendations intended to reduce the potential risk for contamination and subsequent patient infection. pentax is also reminding customers to follow the validated manual reprocessing instructions that pentax issued to all pentax model ed-3490tk duodenoscope customers in april 2016. this action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Pentax is advising users that the validated manual reprocessing procedures included in the current Instructions for Use (RIFU 6217001 S059 R01, April 2016) remain the same. PENTAX reminds its customers of the importance of using the ED-3490TK according to its current labelling. Customers must ensure that all reprocessing personnel are knowledgeable and thoroughly trained on the current Instructions for Use for manual reprocessing of these devices. Meticulous cleaning of the elevator recesses and attention to following all reprocessing instructions are required. Additionally, PENTAX recommends that users immediately remove from use any ED-3490TK duodenoscope that shows visible signs of wear or physical damage. PENTAX will provide annual inspection and servicing to all customers with ED-3490TK duodenoscopes. During on-site inspections, PENTAX fie

Device

Pentax ED-3490TK Video Duodenoscope

Manufacturer

Pentax Medical Pte Ltd
  • Source
    DHTGA