Events

Retiro De Equipo (Recall) de LiNA Xcise Laparoscopic Morcellator

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por GRC Surgical 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-00119-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-02-18
  • 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-00119-1
  • 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
    Grc surgical pty ltd, following recent advice and review of the instructions for use (ifu) of this device by the therapeutic goods administration (tga), is issuing a product correction to replace the ifu previously supplied with his product. the previous ifu has been identified as not containing sufficient warnings to adequately ensure safe use of the device. changes to update the ifu have been reviewed by the tga, and are in response to a tga safety advisory statement following advice by the urogynaecological devices working group on 4th august 2014 regarding the use of laparoscopic power morcellators (https://www.Tga.Gov.Au/alert/laparoscopic-power-morcellators-update-4-august-2014) .
  • Acción
    GRC Surgical Pty Ltd is requesting all the users to quarantine the devices until the existing IFU's are removed from circulation and replaced with the updated IFU. This action has been closed-out on 20/04/2017.

Device

LiNA Xcise Laparoscopic Morcellator
  • Modelo / Serial
    LiNA Xcise Laparoscopic MorcellatorReference No: MOR-1515, MOR-1515-1, MOR-1515-6 ARTG Numbers: 226906 & 180377
  • Manufacturer
    GRC Surgical Pty Ltd

Manufacturer

GRC Surgical Pty Ltd
  • Source
    DHTGA