Events

Alerta De Seguridad para LIGASURE - GENERATOR FOR VALLEYLAB VESSEL SEALING - Registration 10349000188 - Models: Ligasure Five (LS1500) and Ligasure Five Short (LS1520) Vessel Sealing Instrument - Lots Affected LS1500 - S1EB003X and LS1520 - S1FB033PX.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por AUTO SUTURE DO BRASIL.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    1115
  • Fecha
    2012-02-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notas adicionales en la data
    In Brazil no notifications were registered in the National Notification System - NOTIVISA. This voluntary recall is limited to the listed codes and batch numbers and does NOT affect any other lots of Covidien products. #### UPDATE - 01/17/2012 - The company forwarded the file 00411924 / 12-9, where it reports that it has already reached 73% of the clients. #### CONCLUSION - Field action completed, with the collection of 74 units of the affected product, of the 163 units sold. ####
  • Causa
    Potential risk of detachment from a drive handle pin.
  • Acción
    1. Immediately identify and segregate all affected products. 2. Fill in the form for collecting the LigaSure Vessel Sealing Instrument attached, with the quantities in stock. Send the completed form to the email atendimento.brasil@covidien.com. If you do not have any affected lot units in your inventory, simply return the pickup form, indicating that you have zero (0) units. If you have any questions, please contact us on 0800 702 6843.

Device

LIGASURE - GENERATOR FOR VALLEYLAB VESSEL SEALING - Registration 10349000188 - Models: Ligasure F...

Manufacturer

AUTO SUTURE DO BRASIL
  • 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
    ANVSANVISA