Events

Retiro De Equipo (Recall) de Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for gynecological treatments)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Lumenis 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-01331-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-11-07
  • 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-01331-1
  • 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
    Lumenis have learned that the cleaning instructions provided in femtouch operator’s manual (um-10065340 rev. b) might be ineffective for a fully assembled device and may lead to a potential for cross-contamination. lumenis initiated a re-verification of the cleaning protocol, and the results showed the current protocol as stated in the instructions for use (ifu) were not effective for an assembled handpiece (tip). this issue affects all femtouch hand pieces and kits. lumenis has not received any reports of injury or harm associated with this potential risk.
  • Acción
    Lumenis is asking customers to disassemble the FemTouch tip prior to its cleaning process. This will remove cleaning challenges and allow the device to be effectively cleaned and sterilised using the protocol in the labelling, thereby reducing the potential for cross-contamination.

Device

Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for...
  • Modelo / Serial
    Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for gynecological treatments)FemTouch KitModel Number: AC-1007415FemTouch Tip (supplied in FemTouch Kit)Part Number: SPSA-20002590ARTG Number: 204126
  • Manufacturer
    Lumenis Australia Pty Ltd

Manufacturer

Lumenis Australia Pty Ltd