Events

Retiro De Equipo (Recall) de TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew 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-00275-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-03-11
  • 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-2016-RN-00275-1
  • 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
    Topaz microdebrider wands has failed to meet shelf-life at the expiration date indicated on the product labels during internal functional testing. it has been found that saline may leak from the proximal end of the handle during use, and the spacer between the active and return electrodes may be displaced. this can potentially lead to the spacer being unintentionally retained in a patient, which may lead to a prolonged procedure time.
  • Acción
    Smith & Nephew is advising users to discontinue use and return the affected product. Smith & Nephew will be able to provide users with alternate products. This action has been closed-out on 25/01/2017.

Device

TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, kne...
  • Modelo / Serial
    TOPAZ MicroDebrider Wand (used for ablation and microdebridment in the tendons of the ankles, knees and shoulders)Product Number: ACH4040-01All batches affectedARTG Number: 221504
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd