Alerta De Seguridad para Hemorroidal Circular Stapler - Commercial Model PROXIMATE PPH - ANVISA Registration 80145900949 ////. List of affected lots: http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2007/867.pdf

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Ethicon Endo-Surgery.

¿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
    867
  • Fecha
    2007-04-30
  • País del evento
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
  • 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
    The company informs that although this adhesive migration does not affect the trigger mechanism, this can result in audible and tactile feedback at the center point of the activation cycle. This feedback, which can be heard and felt, is sometimes interpreted by some surgeons as the termination of the firing cycle, and may lead the surgeon to prematurely stop the mechanism activation and result in incomplete clamp or cut line formation. through the Technovigilance Unit will be monitoring the case, in order to ensure that health products marketed in Brazil have the safety and efficacy necessary for the good performance of the product
  • Causa
    For certain product units the adhesive used to attach the device sheath may have migrated to the staple driver.
  • Acción
    Collection process (direct contact with customers) Segregation and destruction of the products involved in the deposit of the company

Manufacturer

  • Source
    ANVSANVISA