Events

Retiro De Equipo (Recall) de Thoracic Pedicle Feeler

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2017-RN-01337-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-23
  • 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-2017-RN-01337-1
  • 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
    Stryker has determined that a laser marking machine used to create the distance markings on the tip of the thoracic pedicle feeler has settings higher than those intended. this change leads to an increased energy being directed onto the tip of the thoracic pedicle feeler, causing material degradation where the laser marks exist.There is the potential for the tip of the thoracic pedicle feeler to break during use. if this occurs within the patient, migration of the broken tip could result in soft tissue or peripheral nerve injury requiring surgical intervention.
  • Acción
    Stryker is advising users to quarantine any affected product and contact their local Stryker representative to coordinate the return and replacement of affected product.

Device

Thoracic Pedicle Feeler
  • Modelo / Serial
    Thoracic Pedicle FeelerItem Number: 6002-350-000 (contained within tray 6001035000-T)Serial Number: 10910ARTG Number: 175054
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    DHTGA