Device Recall Covidien 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Covidien LP 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    60901
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0995-2012
  • 사례 시작날짜
    2012-01-12
  • 사례 출판 날짜
    2012-02-13
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-08-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Staple, implantable - Product Code GDW
  • 원인
    Duet trs straight and articulating single use (sulu)loading staplers used in thoracic surgery may result in serious injury or death.
  • 조치
    Covidien issued an Urgent Medical Device Recall letter dated January 12, 2012 to all affected customers. The letter identified the affected products, problem, and actions to be taken. Customers were instructed to immediately discontinue use of the device in thoracic surgery, Immediately advise all surgeons/surgery personnel of this recall and return products intended for thoracic use to Covidien by contacting Customer Service at SDFeedback@Covidien.com or 1-800-722-8772, option 1, to obtain a Return Goods Authorization prior to returning the affected units. Customers were advised to complete the Recall product return form in its entirety and return it with the returned units. For questions contact your Covidien representative or Quality Assurance at 203-492-5232.

Device

  • 모델명 / 제조번호(시리얼번호)
    All lots
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA (nationwide) and the countries of: ¿esk¿ republika, ASSAGAY, Australia, Austria, Belgium, Bosnia, Herzegovina, Bulgaria Cairo,Egypt, Canada, Canary Islands, China, Croatia, Cyprus, Czech Republic, Denmark, Egypt, England, Finland, France, Germany, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kingdom of Bahrain, Korea, Republic of Kuwait, Latvia, Lebanon, Libya, Luxembourg, Nederland, Nelspruit, New Redruth, New Zealand, Norway, Nouvelle Caledonie, Philippines, Poland, Portugal, Qatar, Reunion, Russia, Romania, Rustenburg, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Taiwan, Thailand, Tunisia, Uae, Uae - Dubai, Umhlanga Rocks, United Kingdom, Vietnam and Wales.
  • 제품 설명
    DUET TRS 60 4.8MM ARTICULATING SULU || Product Code: DUET6048A || Product Usage: || The ENDO GIA UNIVERSAL Staplers with Duet TRS SULUs have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures. When used with the ENDO GIA Universal and Ultra Staplers, the Duet TRS Reloads with Biosyn tissue reinforcement place two, triple-staggered rows titanium staples while simultaneously dividing the tissue and anchoring the preloaded Biosyn reinforcement material. The preloaded reinforcement material Is fully detached from the SULU upon complete firing of the length of the cartridge. The Duet TRS reinforcement material (Biosyn) Is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Covidien LP, 60 Middletown Ave, North Haven CT 06473-3908
  • 제조사 모회사 (2017)
  • 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
    USFDA