Events

Recall of ED-530TK Duodenoscope

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Fujifilm 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-2018-RN-00146-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2018-02-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00146-1
  • 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
    In response to recent concerns regarding the ability to thoroughly clean duodenoscopes, fujifilm has redesigned some components of the ed-530xt duodenoscope. corrective actions for the ed-530xt include replacement of the forceps elevator mechanism and o-ring seal, replacement of the distal end cap, and new operation manual. the updated design, maintenance schedule and labelling have all been implemented to help reduce any potential risk to health that may be associated with inadequate reprocessing of the device.Fujifilm, through the distributor c.R. kennedy & co, will provide a revised operation manual to be followed. below is the main update to the operation manual:- added the requirement for the ed-530xt to be returned to local fujifilm dealer or authorised service representative for inspection and replacement of the forceps elevator seal once a year to maintain safe use of the device.
  • Action
    FujiFilm is advising users to review and update the handling and re-processing procedures. Affected products will be serviced to replace the affected parts.

Device

ED-530TK Duodenoscope
  • Model / Serial
    ED-530TK DuodenoscopeSerial Numbers: MD102A129, MD102A130, 1D102K227, 1D102K388, 1D102K394, 1D102K436, 1D102K460, D102K508, 1D102K517ARTG Number: 139172(Fujifilm Australia - Duodenoscope, flexible, video - Dudoenoscope, flexible, video)
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd