Events

Retiro De Equipo (Recall) de Cook LapSac Surgical Tissue Pouch

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-00500-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-19
  • 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-00500-1
  • 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
    Updates to the ifu are being made to discourage use of laparoscopic power morcellation in cases where the presence of cancerous tissue cannot be ruled out. the intended use for the device is being modified from "used to isolate tissue during, or prior to, surgical removal and or morcellation" to "used to isolate tissue during, or prior to surgical removal". a contraindication i.E., 'not for use with power morcellators' is also being added to the ifu. additionally, warnings and instructions in the ifu is being updated.
  • Acción
    Customers are advised to pass the customer letter on to appropriate personnel within their organisation or to any organisation where the potentially affected devices have been transferred. This action has been closed-out on 26/08/2016.

Device

Cook LapSac Surgical Tissue Pouch

Manufacturer

William A Cook Australia Pty Ltd