Events

Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Given Imaging 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
    2012-01-12
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120111.html
  • 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
    Field safety notice: given imaging bravo® ph monitoring system, part number fgs-0312 (5-pak) or fgs-0313 (singles) medical device manufacturer, given imaging, has issued a field safety notice on bravo® ph monitoring system, part number fgs-0312 (5-pak) or fgs-0313 (singles). the manufacturer has received reports of failure of the bravo capsule to attach to the esophagus or failure of the capsule to detach from the placement device. occurrence of these failures may result in lengthened time for a bravo procedure, esophageal injury, and/or the need for additional procedures. upon investigations, the manufacturer determined that these failures have a combination of root causes including issues related to tolerances in certain manufacturing dimensions. the manufacturer will replace the affected devices. an "attention" label on how to perform the rescue procedure and an updated user manual are now being provided with all bravo devices. according to the local supplier, the affected product has been distributed in hong kong. if you are in possession of the product, please contact your supplier for necessary actions.

Device

Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Given Imaging Bravo® pH Monitoring System, part number FGS-0312 (5-Pak) or FGS-0313 (Singles)
  • Manufacturer
    Given Imaging

Manufacturer

Given Imaging
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH