Events

Retiro De Equipo (Recall) de 10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Applied Medical 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-00387-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-05
  • 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-00387-1
  • 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
    Due to inconsistent clip application, the 10mm direct drive clip applier is being recalled. although malformed clips are typically readily apparent to the user, this failure mode may lead to unoccluded vessels.
  • Acción
    Applied Medical is advising users to check inventory for the affected lots and return any affected product. This action has been closed-out on 30/01/2017.

Device

10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopi...
  • Modelo / Serial
    10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures)Product Code: CA090Affected Lot Numbers: 1190181 to 1265006Expiry date: Prior to 18 March 2019Affected Kit Product Codes: CK304, GK306, GK307, GK311, GK312, GK317, GK318, GK323, GK334, GK335, K0509 and K0592ARTG Number: 221008
  • Manufacturer
    Applied Medical Australia Pty Ltd

Manufacturer

Applied Medical Australia Pty Ltd