Events

Retiro De Equipo (Recall) de Fujifilm ED-530XT Duodenoscope

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fujifilm 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-2016-RN-00034-2
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-11
  • 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-2016-RN-00034-2
  • 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 operation manuals have been revised to reflect newly validated manual cleaning and high-level disinfection procedures. this action is being taken as a result of reports of multi-drug resistant bacteria on endoscopesused for endoscopic retrograde cholangiopancreatogram (ercp) procedures. revisions have been made to the ed-530xt operation manuals, “preparation and operation” and “cleaning, disinfection and storage.” these revisions modify the cleaning and disinfection processes and require the use of a new disposable distal end cleaning brush to be used for the cleaning of the duodenoscope’s distal tip, forceps elevator and elevator recess, in addition to use of the existing fujifilm valve cylinder cleaning brush.
  • Acción
    FujiFilm is providing users with updated instructions manuals and samples of the new disposable distal end cleaning brush. All previous versions of the IFU should be discarded. This action has been closed-out on 01/03/2018.

Device

Fujifilm ED-530XT Duodenoscope
  • Modelo / Serial
    Fujifilm ED-530XT Duodenoscope Serial Numbers: MD102A129, MD102A130ARTG Number: 139172
  • Manufacturer
    Fujifilm Australia Pty Ltd

Manufacturer

Fujifilm Australia Pty Ltd