Events

Retiro De Equipo (Recall) de Brainlab Offset Cup Impactor Universal (blue handle)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Brainlab Australia 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-00178-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-07
  • 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-00178-1
  • 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
    An issue has been detected that when the brainlab offset cup impactor universal (blue handle) is reprocessed in a sterilisation tray as described in the current brainlab cleaning, disinfection and sterilisation guide (revision 5.2 and previous versions), the device may not be determined as sterile. the required sterility assurance level (sal) of 10-6 can only be achieved if the device is individually wrapped for sterilisation. if a non-sterile brainlab offset cup impactor universal (blue handle) is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could, directly or indirectly, enter the patient’s body, potentially leading to an infection. at this stage, there have been no reports of affected patients due to this issue.
  • Acción
    Brainlab is advising users to follow the sterilisation instructions in the current version (BL-IL-60960-69ML Rev. 1) of the IFU. Users are reminded that in addition to following the other instructions in the IFU, the Offset Cup Impactor Universal (blue handle) must be sterilized in an individually wrapped configuration.

Device

Brainlab Offset Cup Impactor Universal (blue handle)
  • Modelo / Serial
    Brainlab Offset Cup Impactor Universal (blue handle)Catalogue Numbers: 52856, 52856AARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd