Events

Retiro De Equipo (Recall) de Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit

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-00374-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-29
  • 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-00374-1
  • 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
    There is a potential for the edge of the probe plus ii rotational knob to rub against the tyvek packaging, and in remote instances, puncture the tyvek creating a pin hole and potentially compromising the sterility of the device.
  • Acción
    Johnson & Johnson Medical is recalling the potentially affected products.

Device

Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit
  • Modelo / Serial
    Electrosurgery Probe Plus II (Electrosurgical electrodes) & Laparoscopic Banding Kit Electrosurgery Probe Plus II Monopolar Electrosurgery Suction and Irrigation Shaft with: Hook Electrode - 5 mm (Code: EPS01)Spatula Electrode - 5 mm (Code: EPS02)Right Angle Electrode - 5 mm (Code: EPS03)ARTG Number: 125259Electrosurgery Probe Plus II Suction and Irrigation Shaft - 10 mm ( Code: EPS 11)ARTG Number: 124975 Laparoscopic Banding Kit ( Code: CK260)ARTG Number: 99301
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd