Events

Retiro De Equipo (Recall) de PROSTIVA RF Model 8930 Generator (Used for minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH))

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-2013-RN-00280-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-03-28
  • 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-2013-RN-00280-1
  • 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
    Medtronic has found through device testing that if the foot switch is not connected to the model 8930 rf generator, there is the potential for an electrostatic discharge on the foot switch connector port to toggle the generator rf output on or off. this behaviour mimics the performance of operation of the footswitch.
  • Acción
    Medtronic is sending an insulating cap for placing over the foot switch connector port located on the rear panel of the Model 8930 RF Generator. The insulating cap is not necessary if the foot switch is connected.

Device

PROSTIVA RF Model 8930 Generator (Used for minimally invasive treatment for patients with lower u...
  • Modelo / Serial
    PROSTIVA RF Model 8930 Generator (Used for minimally invasive treatment for patients with lower urinary tract symptoms due to benign prostatic hyperplasia (BPH))ARTG Number: 137006
  • 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