Events

Retiro De Equipo (Recall) de Endo Peanut 5mm Device

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-2017-RN-00633-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-23
  • 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-00633-1
  • 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
    There have been reports that the cotton tip of the device may disengage due to insufficient adhesive application during the manufacturing process. the use of products with this issue may increase the potential for the tip to disengage, resulting in possible extension of operating room time or the need for unintended radiation exposure via x-ray for detection of the foreign body. four injuries have been observed in the field in which the cotton tip disengaged into the patient requiring unanticipated use of x-ray to locate the missing cotton (and in one case the tip was not retrieved subsequent to x-ray).
  • Acción
    Medtronic is requesting users quarantine and discontinue use of the affected item codes and lots. Medtronic will arrange for pick-up of the stock and will provide credit.

Device

Endo Peanut 5mm Device
  • Modelo / Serial
    Endo Peanut 5mm DeviceItem Code:173019Lot Numbers: M5K04X to M7A01XExpiry date: October 2020 through to January 2022ARTG Number:178599
  • 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