Events

Retiro De Equipo (Recall) de PlasmaSORD

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-2015-RN-00112-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-11
  • 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-2015-RN-00112-1
  • 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
    Based on a concern raised in the us relating to the potential risk of transcoelomic spread of undiagnosed cancerous tissue with the use of morcellators in the treatment of uterine fibroids, the manufacturer has issued an updated ifu which has been included in this communication.
  • Acción
    Olympus is notifying hospitals of the expanded contraindications, warnings and risk associated with the use of power morcellators. The TGA has published information on the risks associated with power morcellators on the TGA website at: - https://www.tga.gov.au/alert/laparoscopic-power-morcellators-29-april-2014 - https://www.tga.gov.au/alert/laparoscopic-power-morcellators-update-4-august-2014. This action has been closed-out on 18/07/2016.

Device

PlasmaSORD

Manufacturer

Olympus Australia Pty Ltd