Device Recall PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Endoscopy 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
    69838
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0703-2015
  • 사례 시작날짜
    2014-11-17
  • 사례 출판 날짜
    2014-12-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2015-07-17
  • 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
    Endoscope and/or accessories - Product Code KOG
  • 원인
    The parameters provided in the laparoscopic manual instruments instructions for use (ifu 1000-401-070 revision g or prior) do not support the unwrapped gravity cycle and the ethylene oxide cycle sterilization methods.
  • 조치
    Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to endorecall@stryker.com or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at endorecall@stryker.com. For questions regarding this recall call 408-754-2000.

Device

  • 모델명 / 제조번호(시리얼번호)
    247425 345126 443972 542154 643084 744694 745080 745631 746499 747596 845622 940158 941057 942853 0943888E 0943889E 0945145E 0945724E 1040112E 1040803E 1041624E 1042486E 1042718E 1042721E 1043803E 1046698E 1142619E 1143800E 1145679E 1146359E 114635E 1146663E 1242122E 1242714E 1242919E 1243536E 1243952E 1244528E 1244582E 1244993E 1245516E 1246169E 1246647E 1340192 1340541 1343411 1343710 1344029 1344298 1345423 1345645 1346655 1440435 1440679 1441180 1441180E 1441815 1442256 1442808 1443226 1443650
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
  • 제품 설명
    PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 || Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Stryker Endoscopy, 5900 Optical Ct, San Jose CA 95138-1400
  • 제조사 모회사 (2017)
  • Source
    USFDA