Events

Alerta De Seguridad para ENDOPATH PROBE II ELETROCIRURGY PROBE II. Registro Anvisa: 10132590006. Lots Affected: Products with due dates from 09/2012 to 09/2013, with the following product codes: EPS01 - 34cm (Hook Probe); EPS02 - 34cm (Spatula Probe); EPS03-34cm (Straight Angle Probe); EPS04 - 34cm (Curved Dissector Probe); EPS05 - 29cm (Hook Probe); EPS06 -29cm (Spatula Probe); EPS07 - 29cm (Right Angle Probe); EPS08 - 29cm (Curved Dissector Probe); EPS09 - 29cm (Needle Probe).

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 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
    955
  • Fecha
    2009-03-04
  • 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
    The manufacturer of the product, Ethicon Endo Surgery Inc., detected the problem and found that the presence of free nickel in the product could induce a reaction in patients with nickel sensitivity or even sensitize certain patients exposed to nickel in the future. According to the holder of the product registration in Brazil (Johnson & Johnson do Brasil Ltda), so far no adverse events have been reported so far. Anvisa's Technovigilance Unit is monitoring this case.
  • Causa
    Possibility of degradation of the stainless steel tips of the product, which can result in the release of small amounts of nickel. as a result, there may be a risk to the health of some patients.
  • Acción
    The holder of the product registration in Brazil (Johnson & Johnson do Brasil Indústria e Comércio de Produtos para Saúde Ltda.) Has already begun collecting the product and blocking affected batches in the company's inventory. The recommendations to users and distributors of affected products are as follows: (1) Do not distribute the product with the codes and dates described above (in Product Description); (2) Inspect your product stock immediately and remove the affected affected products, segregating them and identifying them to prevent inadvertent use of them; (3) Contact the product registration holder for return of affected products.

Device

ENDOPATH PROBE II ELETROCIRURGY PROBE II. Registro Anvisa: 10132590006. Lots Affected: Products w...

Manufacturer

Johnson & Johnson do Brasil Ltda