Events

Recall of Pentax PTX-EG-387UTK Ultrasound Video Gastroscope (flexible gastroduodenoscope)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Technologies 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-2012-RN-00819-3
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-08-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00819-3
  • 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 has been notified of a potential risk related to the use of the eg-3870utk ultrasound video gastroscope in combination with aspiration needles if the instructions for use is not followed carefully by the user. specifically, if the user fails to properly position the elevator while advancing the aspiration needle through the endoscope, the needle could disengage from the elevator.
  • Action
    Customers are being provided with revised instructions for use (IFU) which should be read and followed by the users of the equipment. The owners manual is to be updated with the addendum that has been provided by the Sponsor.

Device

Pentax PTX-EG-387UTK Ultrasound Video Gastroscope (flexible gastroduodenoscope)

Manufacturer

Device Technologies Australia Pty Ltd