Events

Versaport Bladeless Optical 5mm Trocar with Fixation Cannula 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Covidien Private Limited 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
  • 날짜
    2013-05-10
  • 사례 출판 날짜
    2013-05-10
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130510.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
    Medical device safety alert: covidien versaport bladeless optical 5mm trocar with fixation cannula medical device manufacturer, covidien private limited issued a medical device safety alert concerning versaport bladeless optical 5mm trocar with fixation cannula. the affected code number are onb5lgf, onb5shf, onb5stf, onb5stf2c, onbfca5sh, onbfca5st and the affected lot numbers range are n2h0414x through, n2h0413x through, n2h0353x through, n2j0211x through, n2j0315x through and n2j0150x through. the special lot numbers (n2h0045x, n2h0166x, n2h0286x, n2h0357x and n2h0516ux) are not affected by this recall and are acceptable for use. covidien has received reports of seals disengaging from the cannula which may result in a component inadvertently disengaging into the patient’s cavity. no related adverse events have been reported at this time. the seal is located within the trocar body itself and when defective, may detach from the trocar and be pushed by the laparoscopic instrument into the body cavity. if detected, the detached seal should be removed. as with all foreign bodies, if undetected and left free in the body, the seal may lead to a complication, the nature of which is undetermined. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 10 may 2013.

Device

Versaport Bladeless Optical 5mm Trocar with Fixation Cannula
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Covidien Versaport Bladeless Optical 5mm Trocar with Fixation Cannula
  • Manufacturer
    Covidien Private Limited

Manufacturer

Covidien Private Limited
  • 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