Events

Retiro De Equipo (Recall) de TJF-Q180V 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 Olympus 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-2015-RN-00475-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-06-03
  • 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-2015-RN-00475-1
  • 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
    Olympus australia is issuing revised manual cleaning and high level disinfection procedures for the tjf-q180v duodenoscope. users are not required to return any devices to olympus.Further to olympus’ safety alert notification issued in march 2015, the manufacturer has since issued new reprocessing procedures applicable to the tjf-q180v duodenoscope. key changes in the new reprocessing procedures are:-- inclusion of a new single use brush (maj-1888), for cleaning around the forceps elevator- increase the number of raising/lowering of the forceps elevator and flushing of the elevator recess during pre-cleaning and manual cleaning.Ancillary cleaning items (single use soft brushes and a new reprocessing manual) have been sent to the relevant endoscopy units pertaining to this recall for product correction.
  • Acción
    Users are asked to implement the new reprocessing procedures for the TJF-Q180V and to ensure that all personnel involved in the reprocessing are knowledgeable and thoroughly trained on the new procedures. This action has been closed-out on 13/10/2016.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd