Events

Rappel de Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Consulting Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2017-RN-00707-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2017-05-30
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00707-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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