Events

Rappel de Thermablate Endometrial Ablation System (EAS)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gytech 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-2015-RN-00360-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-04-24
  • 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-2015-RN-00360-1
  • 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
    The instructions for use (ifu) of the thermablate endometrial ablation system (eas) is updated due to four case reports of uterine perforation. there is an increased risk of patient injury (including damage to non-targeted tissue) if both thermablate eas procedure and hysteroscopic tubal occlusion/sterilisation are performed on the same day.
  • Action
    Additional warning is being added to the IFU as follows : "Do not perform same day Thermablate EAS procedure and hysteroscopic tubal occlusion/sterilization. Thermablate EAS procedure can be safely and effectively performed with nickel titanium inserts in place, however the procedure should only be performed after the 3 month tubal occlusion confirmation test." Gytech Pty Ltd is informing the customers of the additional warning as updated in the Instructions For Use (IFU). The IFU document (Ref. No: LS2101, Rev C) currently supplied with the Disposable Cartridge already includes these changes. This action has been closed-out on 5/08/2016.

Device

Thermablate Endometrial Ablation System (EAS)
  • Modèle / numéro de série
    Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit Product Code: I-22001Thermablate Disposable Cartridge Product Code: 1-21004All Lot NumbersARTG Number: 186661
  • Manufacturer
    Gytech Pty Ltd

Manufacturer

Gytech Pty Ltd