Events

Rappel de Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit

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-2014-RN-00573-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-18
  • 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-2014-RN-00573-1
  • 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
    This action is undertaken to inform users of an update to the instructions for use (ifu) for the thermablate endometrial ablation system (eas). the ifu updates are in the following sections:1) directions for use / treatment - includes an additional precautionary step in the sequence of procedures just prior to inserting the thermablate catheter into the uterus to initiate treatment. the sequence now includes a requirement for a second sounding of the uterus just after dilation and before performing hysteroscopic examination of the uterus to confirm that perforation of the uterus or the creation of a false passage has not occurred during the dilation and soundings.2) contraindications – the current contraindication i.E., “a patient with lower segment c section scar that has a linear scar thickness of less than 1cm” is being amended to “a patient that has had three or more, lower segment c sections and where the linear scar thickness in those patients is less than 8mm”.
  • Action
    Customers are provided with the updated IFU along with the customer letter. This action has been closed-out on 11/02/2016.

Device

Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit
  • Modèle / numéro de série
    Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit KitProduct Code : I-22101 Thermablate Disposable Cartridge Product Code : I-21004ARTG number: 186661
  • Manufacturer
    Gytech Pty Ltd

Manufacturer

Gytech Pty Ltd