Events

Retiro De Equipo (Recall) de AMPLITUDE Orthopaedic Surgical Instruments

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-2014-RN-01059-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-03
  • 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-2014-RN-01059-1
  • 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
    Amplitude identified an error regarding the automated cleaning process in the instructions for use (ref. no103 indices j, k and l) supplied with its surgical instruments since 2012. the protocol is not the correct one and does not correspond to the validated cycle, although it is applicable for the universal handle (ref. 2-0232100). the automated cleaning (washer - disinfector step) in the ifu incorrectly states to process in a solution of alkaline detergent (e.G. 5% mediclean) for 15 minutes at 40°c. the correct procedure is to process in a solution of alkaline detergent (e.G. 0.5% mediclean) for 10 minutes at 93°c.
  • Acción
    A copy of the revised Instructions For Use NO103 – revision M is attached with the customer letter. Amplitude is asking the customers to verify the automated cleaning parameters in the revised instructions for all other Amplitude instruments (except the universal handle). This action has been closed-out on 18/03/2016.

Device

AMPLITUDE Orthopaedic Surgical Instruments

Manufacturer

Amplitude Australia Pty Ltd