Events

Alerta De Seguridad para SURGICAL TROCARS ENDOPATH XCEL. Reg. Anvisa: 80145900744. Verify affected lots at the electronic address: http://portal.anvisa.gov.br/wps/wcm/connect/96016a00448d8eba9820d97d15359461/Carta+aos+Usu%C3%A1rios.pdf?MOD=AJPERES.

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda.; 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
    1030
  • Fecha
    2010-11-03
  • 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
    Ethicon Endo-Surgery manufactures the trocates quoted in this alert as single-use products. In the case of customized kits, users should contact the assembler if they have questions about the products they have in stock. According to information presented by the registry holder, the recall was initiated because the manufacturer detected an increase in leakage reports on ENDOPATH XCELL products with OPTIVIEW technology, potentially potentially leading to loss of pneumoperitoneum during a surgical procedure. series of undesired consequences, such as drawbacks to users or the need to convert a laparoscopic surgery into open surgery. The Anvisa Technovigilance Unit (UTVIG / NUVIG / ANVISA) is monitoring this case.
  • Causa
    Possibility of leakage on ethicon xcell products with optiview technology, which may cause loss of patient pneumoperitoneum during a surgical procedure.
  • Acción
    Products under recall should not be used. Users of the product should take the following steps: (1) inspect your stock immediately and, if you locate an affected product, segregate it by identifying it so that it will not be used inadvertently; (2) Complete the Business Response Form and send to the registration holder (Johnson & Johnson Ltda.), By FAX: (11) 3030-1109, within 3 (three) business days, even if you did not locate the affected product in your inventory - mention Event 2244 in the form; (4) Keep a copy of the form in your records if you have any product to return; (5) To return the product, take a photocopy of the Commercial Response Form and place it in a box, along with the product - await contact of a Johnson & Johnson Ltda representative to ship the product; (6) Share this information with everyone involved with the product in your institution. Commercial Response Form: http://portal.anvisa.gov.br/wps/wcm/connect/fd170580448d8d7897fdd77d15359461/Formul%C3%A1rio+de+Components+Commercial.pdf?MOD=AJPERES

Device

SURGICAL TROCARS ENDOPATH XCEL. Reg. Anvisa: 80145900744. Verify affected lots at the electronic ...

Manufacturer

Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda.; Ethicon Endo-Surgery