Events

Alerta De Seguridad para Linear Endoscopic Stapler ENDOPATH (Reg. 10132590500); Staple Recharge for ENDO-SURGERY Stapler (Reg. 10132590499). Lots affected: please consult http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_932_lotes.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 Inc.; Johnson & Johnson Produtos Profissionais 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
    932
  • Fecha
    2008-07-28
  • 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
    According to information presented by the registry holder, the customers involved have already been communicated through letters of communication of collection (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_932_carta.pdf). Along with the letter to the clients, the company also sent a reimbursement questionnaire to be completed and returned. The Technovigilance Unit is following up on this case.
  • Causa
    Failure to produce a component may cause the staple cartridge to release an incomplete staple line.
  • Acción
    The manufacturer of the products (Ethicon Endo-Surgery Inc.) recently began collecting, on a worldwide basis, certain batches of the Endopath Linear Endoscopic Stapler and Endo-Staple Staple Recharge products. In Brazil, the holder of the product registration with Anvisa (Johnson & Johnson Produtos Profissionais Ltda.) Has already started the collection process with its customers and distributors. The actions recommended to customers are as follows: (1) do not use products with the batch numbers described in the affected batch table; (2) Inspect your inventory immediately to see if you have the affected product (s) and remove it from the stock if so; (3) Complete the recalculation questionnaire (http://www.anvisa.gov.br/tecnovigilancia/alertas/anexos_2008/alerta_932_questiona.pdf) and fax it to Johnson & Johnson Ltda within 3 business days, even if it does not owns the affected product in inventory; (4) To return the product, take a copy of the completed rebuilt questionnaire, place it in the box with the product, set the return authorization provided by your sales representative, and contact Johnson & Johnson Ltd. Professionals Ltda, Rod. Presidente Dutra, km 154 - CEP 12240-908 - São José dos Campos - Brazil).

Device

Linear Endoscopic Stapler ENDOPATH (Reg. 10132590500); Staple Recharge for ENDO-SURGERY Stapler (...

Manufacturer

Ethicon Endo-Surgery Inc.; Johnson & Johnson Produtos Profissionais Ltda