Events

Retiro De Equipo (Recall) de Laser Guide, Endotherapy, single use - TXMF600BFS Fibres, when using pullback device

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Consulting 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-2017-RN-00707-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-05-30
  • 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-2017-RN-00707-1
  • 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
    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.
  • Acción
    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
  • Modelo / Serial
    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