Events

Device Recall ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw 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
    61314
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1247-2012
  • 사례 시작날짜
    2012-01-26
  • 사례 출판 날짜
    2012-03-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-02-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107794
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code LFL
  • 원인
    Ethicon endo-surgery initiated a voluntary global recall for specific production lots of enseal¿ g2 curved and straight tissue sealers due to two potential issues that may occur related to the activation button: (i) continuous activation: the enseal¿ device/system may continue to activate when the activation button is released prior to reaching the end of cycle (tone 3). (ii) no activation.
  • 조치
    Ethicon Endo-Surgery sent an Urgent Medical Device Recall letter dated February 10, 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 immediately stop use of the affected product, fill out the attached Business Reply Form (BRF) and return to and return the affected product to: Ethicon Endo-Surgery ATT: ENSEAL G2 Recall 4545 Greek Road Cincinnati, Ohio 45242 Customers were instructed to choose one of the following response options: Return the Business Reply Form to their sales representative Call 1-800-873-3636, Option 6 Fax the BRF to 1-513-337-4138 For any questions regarding this recall call 513-337-3419.

Device

Device Recall ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw
  • 모델명 / 제조번호(시리얼번호)
    Product Code 00NSLG2S35, Lot #, H44Y6N, Exp Date, Nov-2013, Lot # H44Y8A, Exp Date, Nov-2013, Lot # H44Y8K, Exp Date, Nov-2013, Lot # H44Z65, Exp Date, Nov-2013, Lot # H44Z6J, Exp Date, Nov-2013 & Lot # J4A164, Exp Date, Dec-2013.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AZ, CA, CT, FL, IL, IN, KS, KY, MA, MI, MO, NC, NY, OH, PA, TN & TX and the countries of Arab Emirates, Austria, Belgium, France, Germany, Great Britain, Italy, Jordan, Kingdom of Saudi Arabia, Lebanon, Portugal, Slovenia, Sweden and Turkey.
  • 제품 설명
    ENSEAL¿ Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969 || The ENSEAL¿ G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures. The devices are bipolar electrosurgical instruments for use with an electrosurgical generator. They are intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and to cut, grasp and dissect tissue during surgery. Indications for use include open and laparoscopic, general and gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments.
  • 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