RESOLUTION CLIP DEVICE - Registered in Anvisa under the number 10341350360 - M00522610 - Lot: 0ML9042702 - Boston Scientific do Brasil. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Boston Scientific do Brasil Ltda. 에 의해 제조된 제품과 관련되어 있습니다.

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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
    973
  • 날짜
    2009-07-30
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    We are aware that hospitals often remove the products from their outer packaging and store them on hospital shelves, only in their internal pouches. If this is a practice in your unit, it is very important that you carefully use the table below and consider both the internal code and the external code of the product packaging when searching for affected products of this voluntary recall, since UPN Codes on the labels of the inner packagings of the product are different from those on the outer packagings. The product information listed on your specific Verification and Traceability Response Form (which is attached to this alert). Source: Boston Scientific. ### Update on 11/09/2009 - The company informed Anvisa of the closure of the action for the collection of the affected products through file 749932 / 09-9 dated 10/01/2009.
  • 원인
    It was identified during a manufacturer's inspection and testing process that the torque conductor used to insert the set of screws that connect the control wire to a cross pin of the resolution® clips device was out of calibration. this may result in an inability to position or release catheter.
  • 조치
    The actions recommended to product users are as follows: (1) Immediate discontinuation of use and segregation of the affected product in this alert. (2) Complete and return the verification and traceability response form to: Boston Scientific of Brazil - A / C: Carolina Yin - Fax: (11) 5502-8510 or e-mail: yinc@bsci.com.

Manufacturer