Events

Alerta De Seguridad para Product: Endo Gia Ultra Universal Stapler. Model (s): EGIAUXL, EGIAUSTND and EGIAUSHORT. Anvisa Registry n ° 10349000302.

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 LTDA; Covidien llc; Covidien.

¿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
    1794
  • Fecha
    2016-01-14
  • 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
    If the instrument does not fire or trip partially, or if the hinge lever loosens, the surgeon may need to replace the device to continue the procedure. According to the company, no injuries have been reported in patients who have been caused by these problems.
  • Causa
    1) instruments fail to fire or fire partially; and 2) disengagement of the articulating lever of the instrument during use occurs.
  • Acción
    The product is being recalled. Unused products of affected item and batch codes must be returned as described in the Required Actions section of the company's customer alert message. If you have distributed the Endo GIA ™ Ultra Universal Stapler to other people or units, immediately forward the information in this alert and the company release to these recipients. All affected units must be returned. Company code for the field action: FAEGIA. Access the alert message to customers at: http://portal.anvisa.gov.br/wps/wcm/connect/e1cedb004b5205bf8841b8e16860cb38/Carta+ao+Client+1794.PDF?MOD=AJPERES

Device

Product: Endo Gia Ultra Universal Stapler. Model (s): EGIAUXL, EGIAUSTND and EGIAUSHORT. Anvisa R...

Manufacturer

AUTO SUTURE DO BRASIL LTDA; Covidien llc; Covidien
  • 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