Events

Recall of Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes

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-2013-RN-01053-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01053-1
  • 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
    Device technologies australia (dta) in conjunction with the manufacturer is informing users of an important change in the instructions for use (ifu) for the reliance endoscope processing system (eps) when processing specific fujinon g5 and g8 type flexible gi endoscopes. when set up as defined in the ifu the air pipe on specific fujinon endoscopes doesn’t receive forced flow during the processing cycle. a new steris flow unit 7 has been developed to facilitate forced flow of high level disinfecting solution through the air pipe and is required for reliance eps processing of any impacted fujinon devices. a new “quick reference guide” has been developed to incorporate these changes.
  • Action
    Device Technologies is providing their customers with a new “Quick Reference Guide” and requesting that reprocessing G5 and G8 type endoscopes is discontinued until the correct flow unit #7 is provided.

Device

Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI Endoscopes
  • Model / Serial
    Reliance Endoscope Processing System (EPS) used with FUJINON G5 and G8 Type Flexible GI EndoscopesMultiple FUJINON G5 and G8 Type Flexible GI Endoscope series affectedARTG Number: 112590
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd