Events

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

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-2015-RN-00432-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-05-22
  • 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-00432-1
  • 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 evotech endoscope cleaner and reprocessor (ecr) may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. the likelihood of this occurrence is low, and asp has not received complaints or reports of adverse events related to this issue.The evotech ecr is designed to verify endoscope connections for each cycle. if an improper connection is detected, the system is designed to stop and cancel the cycle. this system detection, along with a user verification step stated in the user’s guide to verify the connections of the endoscope channels before and after the completion of a cycle, help to ensure that an endoscope has been processed properly.As a result sites may need to manually process endoscopes which may increase processing time. an accumulation of processing time may result in surgical delay or rescheduling patients.
  • Acción
    A workaround is provided via the Customer Letter whilst a permanent fix is developed. This action has been closed-out on 03/03/2016.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR)

Manufacturer

Johnson & Johnson Medical Pty Ltd