Events

Alerta De Seguridad para MICROPROCESSED ELECTRONIC BISTURI, model SS-501SX, class III, register 10247670046, serial numbers: 561; 773; 779; 802; 638; 774; 796; 803; 645; 775; 797; 804; 647; 776; 799; 805; 649; 777; 800; 806; 650; 778; 801 and 807.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por WEM Equipamentos Eletrônicos Ltda.

¿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
    1802
  • Fecha
    2016-01-22
  • 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
    Using the wrong pedal does not allow the use of the equipment in bipolar or macrobipolar cut functions. Under these conditions the surgeon can not get cut in the tissue when the equipment is used, but will be able to obtain the coagulation of the fabric. If the equipment is used under such conditions, prolonged exposure may cause point hemostasis by desiccation of the tissue.
  • Causa
    Shipment of equipment with incorrect bipolar pedal to activate the bipolar functions of the equipment. the expedition was made with fs-18 pedal and the fs-23 model was necessary. when the equipment is used with the fs-18 (incorrect) pedal, the main functions of the equipment operate correctly, but the activation of the equipment's bipolar function (bipolar cut and macrobipolar function) fails.
  • Acción
    Field correction. Action code: CAPA015 / 15. The company advises customers to segregate the electrosurgical unit and replace the incorrect pedal FS-18 with the new FS-23 model shipped with the customer communication letter. The pedal replacement immediately corrects the operation of the bipolar and macrobipolar cut modes of the equipment. The segregated pedals will be collected by authorized dealers.

Device

MICROPROCESSED ELECTRONIC BISTURI, model SS-501SX, class III, register 10247670046, serial number...

Manufacturer

WEM Equipamentos Eletrônicos Ltda
  • 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