Events

Retiro De Equipo (Recall) de Covidien Emprint Percutaneous Antennas with Thermosphere Technology

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-01018-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-08-10
  • 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-01018-1
  • 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 have received reports that the ceramic trocar tip of the emprint ablation antenna is disengaging from the needle shaft post-ablation. tip disengagement can result in the ceramic trocar tip remaining in the patient presenting a risk of latent migration and potential damage to adjacent tissue. four of the complaint reports indicate that the trocar tip was not retrieved.
  • Acción
    Medtronic is requesting customers: 1.Quarantine and discontinue use of the specified item codes and lots; 2.Immediately advise all surgeons/surgery personnel of this recall; 3. Check if their facility has distributed the affected products to other persons or facilities, if so, please promptly forward a copy of this letter to those recipients; 4. Email the completed Recall Response Form supplied with the customer letter to Medtronic's Regulatory Affairs Department at ANZ.Recalls@covidien.com or fax to 02 8904 8798. Please include a copy of the Recall Response Form with the returned units; and 5. Label the goods with the provided (ZRE#) for easy identification. Do not return goods without the corresponding ZRE# provided by Medtronic.

Device

Covidien Emprint Percutaneous Antennas with Thermosphere Technology
  • Modelo / Serial
    Covidien Emprint Percutaneous Antennas with Thermosphere TechnologyEmprint Percutaneous Antenna with Thermosphere Technology, Short (15cm)Item Code: CA15L1Emprint Percutaneous Antenna with Thermosphere Technology, Standard (20cm)Item Code: CA20L1Emprint Percutaneous Antenna with Thermosphere Technology, Long (30cm)Item Code: CA30L1Lot Numbers beginning with S5L through S7GExpiration: November 2017 through July 2019ARTG Number: 178369
  • Clasificación del producto
    General and Plastic Surgery Devices
  • 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