StoneBreaker Pneumatic Lithotripter and associated accessories 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Cook Medical 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
  • 날짜
    2018-03-15
  • 사례 출판 날짜
    2018-03-15
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: cook medical stonebreaker pneumatic lithotripter and associated accessories medical device manufacturer, cook medical, has issued a medical device safety alert concerning its stonebreaker pneumatic lithotripter and associated accessories. the products are listed below: product brand name: a) stonebreaker pneumatic lithotripter: b) stonebreaker exhaust cap; c) stonebreaker exhaust line; d) stonebreaker probe cap; e) stonebreaker sterilization cap; f) stonebreaker co2 cartridge; g) stonebreaker single use probe. catalog identifier: a) sbl-kit1; b) sba-ec; c) sba-el; d) sba-pc; e) sba-sc; f) sba-10; g) sbp-010500, sbp-010605, sbp-016500, sbp-016605, sbp-020425. lot number: all the manufacturer is initiating a voluntary recall of the affected products, which are intended for reprocessing at the user’s facility. the manufacturer has identified that the interior of the products may not be sterilized to the appropriate sterility assurance level when following the reprocessing instructions provided in the instruction for use (ifu). according to the manufacturer, the potentially adverse events may occur include urinary tract infection, pyelonephritis, and urosepsis. the users are advised to examine inventory immediately to determine if they have affected products and quarantine affected products. products recall is on-going. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of any affected units, please contact your supplier for necessary actions. posted on 15 march 2018.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Cook Medical StoneBreaker Pneumatic Lithotripter and associated accessories
  • Manufacturer

Manufacturer