Events

Retiro De Equipo (Recall) de Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)

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-2013-RN-00680-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-07-11
  • 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-2013-RN-00680-1
  • 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 a small number of reports where the pump may be supplied with the pump head in the unlocked position. if the pump head is unlocked, this may cause the pump to stop and go into stand-by mode. as a result, no water will be delivered to the endoscope.
  • Acción
    Olympus are requesting users to discontinue use of the affected devices. An Olympus Field Service Technician will perform an inspection and modification if required. Olympus is also providing inspection and modification instructions should the end user wish to correct the device. At the time of agreement 17 customers had received the correction. These customers have been provided with the product correction information for their records.

Device

Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)
  • Modelo / Serial
    Olympus OFP-2 Flushing Pump (used with endoscopic irrigation)Multiple Lot Numbers affected.ARTG Number: 145859
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd