Events

Retiro De Equipo (Recall) de Covidien Emprint Percutaneous Antenna (short, standard & long) with Thermosphere Technology (used with microwave generator for coagulation of soft tissue)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Covidien 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-00210-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-02-26
  • 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-00210-1
  • 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
    This recall is being conducted following customer reports of the emprint ablation generator shutting down due high temperature measurements in the emprint percutaneous antenna.If the generator shuts down due to elevated temperature readings at the antenna tip, the antenna must be replaced and the ability to tract ablate is limited. antenna replacement can result in a delay in treatment or the inability to treat and increases the risk of bleeding and, in the case of lung procedures, the occurrence of pneumothorax. there have been no reports of serious injury associated with this recall.
  • Acción
    Covidien is advising users to quarantine and discontinue use of the affected units. Covidien will arrange for the recovery of these units and the issuance of credit to the affected customers.

Device

Covidien Emprint Percutaneous Antenna (short, standard & long) with Thermosphere Technology (used...
  • Modelo / Serial
    Covidien Emprint Percutaneous Antenna (short, standard & long) with Thermosphere Technology (used with microwave generator for coagulation of soft tissue)Item codes: CA15L1, CA20L1, CA30L1Multiple lot numbers affectedARTG number: 178369
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Manufacturer
    Covidien Pty Ltd

Manufacturer

Covidien 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