Events

Device Recall Raptor 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 US Endoscopy Group Inc 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
    63196
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0006-2013
  • 사례 시작날짜
    2011-11-14
  • 사례 출판 날짜
    2012-10-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112953
  • 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
    Dislodger, stone, flexible - Product Code FGO
  • 원인
    When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.
  • 조치
    US Endoscopy initiated a Voluntary Product Recall letter initiated November 11, 2011. The letter identified the product the problem and the action needed to be taken by the customer. US Endoscopy will provide a free replacement or grant your facility a credit toward a future purchase for every device that is returned to US Endoscopy or verified as having been used or destroyed. For further questions please call 440-639-4494 ext. 378.

Device

Device Recall Raptor
  • 모델명 / 제조번호(시리얼번호)
    Model #00711177; S/N: 52979, 52981, 52982, 53643, 53644, 53891, 53892, 54238
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, and WI; and to the following countries: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Caribbean, Chile, Columbia, Croatia, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Finland, France, Germany, Great Britain, Greece, India, Ireland, Israel, Italy, Jordan, Lithuania, Malta, Mexico, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Romania, Saudi Arabia, Slovenia, South Africa, Spain, Switzerland, Turkey, and United Arab Emirates.
  • 제품 설명
    Endoscopic retrieval device. || The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
  • Manufacturer
    US Endoscopy Group Inc

Manufacturer

US Endoscopy Group Inc
  • 제조사 주소
    US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
  • 제조사 모회사 (2017)
    Steris Plc
  • Source
    USFDA