Events

Retiro De Equipo (Recall) de E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Amplitude 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-01625-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-06
  • 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-01625-1
  • 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
    Following a customer complaint about the e.To.I.L.E extension table, an analysis of the device showed a failure due to an abnormal wear in the locking system of the external rotation. a failure of the rotation locking mechanism would mean that the rotation of the leg would not be able to be maintained and may have the following consequences:- an increase in the surgery timeline if the incident occurs at the beginning of the surgery.- a risk of injury for the patient if the incident occurs during surgery.There have been no reported patient injuries. as a precautionary measure, amplitude decided to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.
  • Acción
    Amplitude is arranging for the return of all devices for preventative maintenance. Replacement devices will be provided as necessary.

Device

E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)
  • Modelo / Serial
    E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)Reference: 3-0499902Serial Numbers: 1500044, E1210021, E1210022, E1210023ARTG Number: 216762
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd