Events

Retiro De Equipo (Recall) de Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)

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-2013-RN-00414-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-05-10
  • 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-2013-RN-00414-1
  • 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
    Covidien has received reports of seals disengaging from the cannula which may result in a component inadvertently disengaging into the patient's abdominal and thoracic cavity.
  • Acción
    Covidien is asking customers to quarantine and discontinue use of all affected lot numbers. Covidien will arrange for pick-up of the affected lots.

Device

Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)
  • Modelo / Serial
    Versaport Bladeless Optical 5mm Trocar with Fixation Cannula (Abdominal and thoracic trocar)Multiple product codes and lot numbers:ONB5LGF (Lots N2K0019X through N3A0294X)ONB5SHF (Lots N2J0265X through N3A0391X)ONB5STF (Lots N2H0353X through N3D0033X)ONB5STF2C (Lots N2J0211X through N3D0118X)ONBFCA5SH (Lots N2J0315X through N3A0389X)ONBFCA5ST (Lots N2J0150X through N3C0683X)ARTG Number: 178557
  • 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