ECHELON ENDOPATH Endoscopic Linear Cutter Reloads in Sleeve Gastrectomy Procedures 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Ethicon 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
    2014-09-16
  • 사례 출판 날짜
    2014-09-16
  • 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: ethicon echelon endopath endoscopic linear cutter reloads in sleeve gastrectomy procedures medical device manufacturer, ethicon, has issued a field safety notice concerning endopath endoscopic linear cutter reloads in sleeve gastrectomy procedures. the affected code numbers are ecr60m, ecr60w, ecr60b, ecr60d, ecr60g and ecr60t. the manufacturer recognizes the criticality of surgeon expertise in pairing tissue type with the appropriate reload to deliver optimal surgical outcomes. as commitment to surgeons and patient safety, the manufacturer want to share some important information about reload selection for ethicon’s endopath endoscopic linear cutter reloads as it relates to laparoscopic sleeve gastrectomy procedures. the manufacturer would like to reinforce the following from the instructions for use of ethicon’s echelon endopath and echelon flex family of staplers: tissue thickness should be carefully evaluated before firing any stapler. if tissue cannot comfortably compress to the closed staple height listed in the table, or easily compresses to less than the closed staple height listed in the table, the tissue is contraindicated as it may be too thick or too thin for the selected staple size. selection of the appropriate staple cartridge should be based upon the combined thicknesses of both the tissue and the staple- line reinforcement material. because any given stapler reload performance may be stressed at tissue thicknesses that cannot comfortably compress to a reload’s closed staple height, moving towards larger staple reloads may improve performance in these thicker gastric tissues. echelon black reload was specifically designed to meet the clinical needs for a thicker tissue application. the manufacturer advises users to share this information with any of the staff involved in laparoscopic sleeve gastrectomy procedures. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 16 september 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Ethicon ECHELON ENDOPATH Endoscopic Linear Cutter Reloads in Sleeve Gastrectomy Procedures
  • Manufacturer

Manufacturer