Events

Safety Alert for 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.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Ethicon Endo-Surgery Inc.; Johnson & Johnson Produtos Profissionais Ltda.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    932
  • Date
    2008-07-28
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    Failure to produce a component may cause the staple cartridge to release an incomplete staple line.
  • Action
    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