Events

Device Recall The ECHELON 60 Endoscopic Linear Cutter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ethicon Endo-Surgery 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
    61750
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1627-2012
  • 사례 시작날짜
    2012-03-02
  • 사례 출판 날짜
    2012-05-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108915
  • 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
    There is a possibility of a component breakage, which may cause the device to stay locked on tissue after firing. if the component exhibits this issue, the device does not open either with the anvil release button or with the manual firing release lever.
  • 조치
    Ethicon Endo-Surgery sent an Urgent Device Recall letter dated March 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately to determine if they have the affected product and to remove the affected product. Fill out the Business Reply Form and fax it to 1-513-337-4138 within 3 business days, even if they do not have the affected product in their inventory. Ethicon will automatically replace any affected product returned by June 29, 2012. Customers were asked to share this information with appropriate staff. If customers should need clinical or product support call 1-800-873-3636, option 6, or contact their local sales representative. For questions regarding this recall call 513-337-7000.

Device

Device Recall The ECHELON 60 Endoscopic Linear Cutter
  • 모델명 / 제조번호(시리얼번호)
    Model # EC60: H44T06, J4A56P, J4A67X, H44T6E, J4A650, J4A762, J4A49A, J4A65N, J4A766, J4A49G, J4A677, J4A76F, J4A567, J4A67D, J4A76L, J4A56F, J4A67H, J4A771; Model # LONG60 lots: H44R8A , H44U3R , H44X17 , J4A55E , J4A64A; Model # SC60: H44R6C, J4A777, J4A58D, J4A77F, J4A58N, J4A78Y, J4A58P.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including AL, AR, CA, CO, FL, IA, IL, KS, LA, MD, MO, MS, NC, NM, NY, OH, SC, TX & VA; and the countries of Argentina, Ecuador, Mexico, Australia, Egypt, Singapore, Belgium, Greece, Slovenia, Brazil, India, South Africa, China, Israel, United Arab Emirates, Colombia, Japan & Venezuela.
  • 제품 설명
    The ECHELON 60 Endoscopic Linear Cutter - Straight, compact ECHELON 60 Endoscopic Linear Cutter - Straight, and the Long ECHELON 60 Endoscopic Linear Cutter - Straight are sterile, single patient use instruments that deliver staples while simultaneously dividing tissue between rows. ECHELON 60 instruments with white, blue, gold, and green reloads deliver two triple-staggered rows of staples. The instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. A staple retaining cap on the reload protects the staple leg points during || shipping and transportation. Sterile products are individually packed in a transparent tray sealed with Tyvek¿. Each tray is placed in an individual carton. 3 individual cartons are placed in a corrugated shipper. || The ECHELON 60 Endoscopic Linear Cutter  Straight, Compact ECHELON 60 Endoscopic Linear Cutter  Straight, and the Long ECHELON 60 Endoscopic Linear Cutter  Straight are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials.
  • Manufacturer
    Ethicon Endo-Surgery Inc

Manufacturer

Ethicon Endo-Surgery Inc
  • 제조사 주소
    Ethicon Endo-Surgery Inc, 4545 Creek Rd, Cincinnati OH 45242-2803
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA