Events

Recall of Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Device Consulting 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-2017-RN-00707-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00707-1
  • 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 consulting has received three reports of the fibre sliding inside the sheath when the pullback device was being used. to date, no injuries have been reported. it has been determined by the manufacturer that when a pullback device is in use, the fibre can slide inside the sheath because the tuohy borst adaptor does not grip the fibre firmly due to a faulty o-ring. should this occur during a procedure on a patient, surgical intervention would be required to remove the section of sheath that had separated.
  • Action
    Device Consulting will be replacing all units from the affected batches at facilities which use pullback devices. In the interim, TXMF600BFS fibres can continue to be used until the replacement is received provided that users pullback manually by pulling the sheath.

Device

Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device
  • Model / Serial
    Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback deviceBatch Numbers: 1606018 and 1607019ARTG Number: 221756
  • Manufacturer
    Device Consulting Pty Ltd

Manufacturer

Device Consulting Pty Ltd