Events

Retiro De Equipo (Recall) de HF Cable used with ESG-400 Electrosurgical Generator (bipolar)

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-2016-RN-01161-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2016-09-07
  • 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-01161-1
  • 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 is notifying users of the reoccurrence of potential error codes for the olympus wa00014a hf cable. although procedures can continue by troubleshooting and clearing error codes in accordance with the esg-400 instructions for use (section 8.2), olympus is highlighting instances of the following error codes when the device is connected: - e618 ‘data transfer’, - e486 ‘no instrument connected’; or, - a pop up message ‘use default instrument settings’ there have been no australian reports of these error codes or incidents with patient injury worldwide. error codes typically only occur in the rare event of rapid activation, such as re-activating the esg-400 electrosurgical generator within 0.2 seconds after the last activation.
  • Acción
    Olympus is advising users that if the error occurs, to troubleshoot as per the Instructions for Use (IFU) to continue the procedure, and notify Olympus to obtain a replacement cable. This action has been closed-out on 12/05/2017.

Device

HF Cable used with ESG-400 Electrosurgical Generator (bipolar)
  • Modelo / Serial
    HF Cable used with ESG-400 Electrosurgical Generator (bipolar)Product Code: WA00014A ARTG Number: 194874
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd