Events

Retiro De Equipo (Recall) de Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool 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 Cochlear 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-00452-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-04-16
  • 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-00452-1
  • 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 cochlear baha soft tissue gauge, part #95070 may have a manufacturing imperfection in the smooth surface of the metal. while this imperfection is minimal, cochlear's risk analysis has indicated that it could potentially leave residual metal on the patient’s skin. to date there have been no adverse events reported to cochlear associated with the use of this instrument.
  • Acción
    Cochlear will remove and replace current Soft Tissue Gauge with an unaffected instrument as quickly as possible. This new instrument has passed additional inspection under microscope to ensure it is not affected by this issue. The instruments removed from the field will also be subjected to the additional inspection under microscope and, if unaffected, be returned for use as required. Any instruments failing additional inspection under microscope will be scrapped. There is no change to clinical management guidelines for patients who have had implant surgery using this instrument.

Device

Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit)
  • Modelo / Serial
    Cochlear Baha Soft Tissue Gauge (included in the Cochlear Baha Attract surgical tool kit) Part Number: 95070ARTG Number: 205705
  • Manufacturer
    Cochlear Ltd

Manufacturer

Cochlear Ltd