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-2016-RN-00098-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-01-27
  • 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-00098-1
  • 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 has received reports of patient infections associated with the elevator sealing mechanism of the tjf-q180v duodenoscope. olympus is updating the existing tjf-q180v operation manual, the tjf-q180v reprocessing manual and will perform a correction to the forceps elevator mechanism. this is further to the urgent recall for product correction notification issued in june 2015 (tga ref: rc-2015-rn-00475-1).
  • Acción
    Affected units can continued to be used, provided the leakage test as outlined in the revised Reprocessing Manual is performed before every use. Olympus is providing instructions for users to access the updated Operation and Reprocessing Manual. Olympus is undertaking a correction of all affected TFJ-Q180V elevator mechanisms and will provide users with loan units whilst the units are being repaired. This action has been closed-out on 27/02/2017.

Device

TJF-Q180V Duodenoscope

Manufacturer

Olympus Australia Pty Ltd