Events

Retiro De Equipo (Recall) de GF-UCT180 Ultrasonic Gastrovideoscope

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-00909-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-09-11
  • 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-2015-RN-00909-1
  • 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
    The nature of this product correction is to issue a revised instruction for use (ifu) which includes instructions on how to correctly clean the device. there is a risk of patient-to-patient infection if the device is not cleaned appropriately. key changes in the new instruction for use are highlighted below:· inclusion of instruction on how to attach the cleaning adapter (maj-350) to the instrument channel port of the gf-uct180· the balloon applicator (maj-675) and the cleaning brush (maj-1534) are to be reprocessed for reuse. the maj-675 and maj-1534 are to be reprocessed in accordance with step “cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment”.
  • Acción
    Olympus is advising their customers of the amendments to the IFU. Customers can request a new IFU by contacting Olympus. Hospitals are advised that a review of internal hospital protocols should be conducted to ensure compliance with the updated cleaning instructions. This action has been closed-out on 29/08/2016.

Device

GF-UCT180 Ultrasonic Gastrovideoscope

Manufacturer

Olympus Australia Pty Ltd