Events

Retiro De Equipo (Recall) de Medtronic Navigated Cannulated Taps

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia 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-00473-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-06-02
  • 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-00473-1
  • 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
    Cannulated taps have the potential to accumulate bone and other tissues in the cannula. use without a guide wire can increase this possibility. medtronic has received reports of user injuries occurring during the cleaning process of cannulated taps that have bone material in the cannula of the devices.
  • Acción
    Medtronic is modifying the instructions for use for the cannulated taps to clearly detail the potential for bone/tissue accumulation in the cannula of the devices if they are used without a guide wire and to caution the user during the cleaning process. If the obstruction in the cannula cannot be removed, the instructions for use indicate that the devices should be considered at the end of their useful life and should be discarded in accordance with your facility procedures and guidelines. The revised instructions for use are provided with the customer letter. This action has been clsoed-out on 24/08/2016.

Device

Medtronic Navigated Cannulated Taps
  • Modelo / Serial
    Medtronic Navigated Cannulated TapsMultiple model numbers affectedARTG Number: 120114, 126291
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA