Events

Retiro De Equipo (Recall) de EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-00319-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-12
  • 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-00319-1
  • 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
    Johnson & johnson medical is issuing a product correction for the evotech endoscope cleaner and reprocessor system after receiving reports of smoke emanating from the system and upon further investigation has discovered that a circuit board malfunction may occur in the channel control manifold sub-assembly. this failure can potentially cause the following outcomes for the cycles: 1. full reprocessing cycle (cleaning and hld) - if this issue were to occur while running a full automated cleaning and high level disinfection (hld) cycle, there is potential for residual rinse water and/or alcohol to remain in the endoscope channels after the cycle completes, 2. hld-only cycle - if this issue were to occur during reprocessing of endoscopes qualified for the hld only cycle, there is potential for an inadequate amount of high-level disinfectant solution to be sent through some endoscope channels.
  • Acción
    Johnson & Johnson Medical Pty Ltd is providing the users with the instructions to prevent the issues from occurring.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
  • Modelo / Serial
    EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)Product number: 50004ARTG: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd