Events

Alerta De Seguridad O Notificaciones De Seguridad para Ligasure blunt tip laparoscopic sealer/divider

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Covidien.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Número del evento
    MDA/2011/026
  • Fecha
    2011-03-15
  • Fecha de publicación del evento
    2014-12-17
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/medical-device-alert-ligasure-blunt-tip-laparoscopic-sealer-divider-potential-risk-of-serious-thermal-burns
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
    During diathermy (electrosurgery) procedures the device may spontaneously energize when clamping, without the activation button being pushed.Although no injuries have been reported, this could cause an unintended energy delivery to tissue resulting in serious thermal burns.
  • Causa
    (covidien) device may spontaneously energize when clamping during diathermy (electrosurgery) procedures without pushing the activation button, which could lead to unintended energy delivery to tissue. (mda/2011/026).
  • Acción
    The manufacturer is conducting a recall of specific lots.Identify affected devices from the lot numbers indicated on the Field Safety Notice (see appendix). Quarantine any affected devices and arrange for their return to Covidien.The MHRA is issuing this alert as there has been a poor response from users to the recall.

Device

Ligasure blunt tip laparoscopic sealer/divider
  • Modelo / Serial
  • Descripción del producto
    Ligasure blunt tip laparoscopic sealer/divider.Manufactured by Covidien.Catalogue number: LF1537.Specific lot numbers.
  • Manufacturer
    Covidien

Manufacturer

Covidien
  • Dirección del fabricante
    Covidien (UK) Commercial Ltd 154 Fareham Road Gosport Hampshire PO13 0AS Tel: 01329 224000 Fax: 01329 224418Email: PRMS.ComplaintsDepartment@covidien.com
  • 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
    MHRA