Events

Retiro De Equipo (Recall) de Pentax ED-3490TK Video 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 Hoya Lens 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-00238-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-07
  • 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-00238-1
  • 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
    Pentax is issuing updated, validated manual reprocessing instructions for the ed-3490tk video duodenoscope to replace those provided in the original device labelling. the updated reprocessing instructions for the ed-3490tk video duodenoscope include a more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilisation procedures. in addition, updated instructions include additional text, figures, cautions and warnings intended to clarify the validated reprocessing procedure.If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection.
  • Acción
    Pentax is providing affected customers with updated Instructions for Use intended to clarify the validated reprocessing procedure. This action has been closed-out on 27/01/2017.

Device

Pentax ED-3490TK Video Duodenoscope

Manufacturer

Hoya Lens Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    HOYA Corp.
  • Source
    DHTGA