Events

Retiro De Equipo (Recall) de Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ConvaTec 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-00923-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-07-12
  • 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-00923-1
  • 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
    Convatec (australia) pty ltd is issuing an instruction for use (ifu) for their unomedical brand frazier suction instrument which currently is supplied without an ifu. this action is being taken in response to complaints from the users in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip. if the issue were to occur, it would result in a loss of suction and loss of visibility in the surgical field. there have been no reports of injuries as a result of this issue.
  • Acción
    The manufacturer has decided to issue an IFU to instruct the users on how to use the product appropriately to avoid any breakage of the instrument. ConvaTec is providing hospitals with the IFU along with the customer letter. This action has been closed-out on 07/02/2017.

Device

Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)
  • Modelo / Serial
    Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)Product Codes: 309.02.006, 309.02.008, 309.02.008L, 309.02.010, 309.02.010L, 309.02.012, 309.02.012LAll lots affectedARTG Number: 172620
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd