Events

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. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Ethicon Endo-Surgery Inc.; Johnson & Johnson Produtos Profissionais Ltda 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    932
  • 날짜
    2008-07-28
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    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.
  • 원인
    Failure to produce a component may cause the staple cartridge to release an incomplete staple line.
  • 조치
    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