Events

Retiro De Equipo (Recall) de Thermablate Endometrial Ablation System (EAS)Thermablate Treatment Control Unit Kit

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-2014-RN-00573-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-18
  • 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-2014-RN-00573-1
  • 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
    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”.
  • Acción
    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
  • Modelo / Serial
    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