Events

Retiro De Equipo (Recall) de Thermablate Endometrial Ablation System (EAS)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Gytech Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-00360-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-04-24
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00360-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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)
  • Modelo / Serial
    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