Events

Retiro De Equipo (Recall) de OER-AW Endoscope Reprocessor

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-2017-RN-00130-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2017-01-30
  • 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-00130-1
  • 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
    There is an update of the operation manual for the oer-aw endoscope reprocessor to instruct users of non-detachable distal cover type duodenoscopes, such as the tjf-q180v duodenoscope, to follow the pre-cleaning and manual cleaning as stated in the duodenoscope’s reprocessing manual prior to setting them into the oer-aw.The following warning has been added to the list of compatible endoscopes/connecting tubes and chapter 4 “basic endoscope reprocessing operations” of the oer-aw operation manual - "when reprocessing the following non-detachable distal cover type duodenoscopes using oer-aw, conduct pre-cleaning and manual cleaning as detailed in each duodenoscope’s reprocessing manual".
  • Acción
    Olympus is requesting users to inspect their inventory and replace any existing OER-AW Operation Manuals and List of Compatible Endoscopes/Connecting Tubes with the latest version supplied.They are further advised to implement the instructions enclosed in the updated OER-AW Operation Manual. This action has been closed-out on 06/07/2017.

Device

OER-AW Endoscope Reprocessor
  • Modelo / Serial
    OER-AW Endoscope ReprocessorImpacted models of duodenoscopes: JF-20, JF-140F, TJF-M20, TJF-30, TJF-145, TJF-140F, TJF-150, TJF-160F, TJF-160VF and TJF-Q180VARTG Number: 185051
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd