Events

Device Recall Endoscope Clip applier, Implantable Fastener and Accessories 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Endogastric Solutions 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
    64395
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1136-2013
  • 사례 시작날짜
    2013-02-04
  • 사례 출판 날짜
    2013-04-17
  • 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=116023
  • 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
    Endoscopic suture/plication system, gastroesophageal reflux disease (gerd) - Product Code ODE
  • 원인
    Esophyx2plus device was not validated under actual or simulated use conditions prior to distributing the product to physicians.
  • 조치
    EndoGastric Solutions, Inc. sent an Urgent Medical Device Recall letter dated January 31, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and record lot numbers for any affected product. If no product remain in inventory customers were instructed to report such to customer service. Upon receipt of the product a credit will be issued for each device returned. For any questions customers were instructed to call 425-307-9226. For questions regarding this recall call 425-307-9200.

Device

Device Recall Endoscope Clip applier, Implantable Fastener and Accessories
  • 모델명 / 제조번호(시리얼번호)
    Lots 401378, 401392, 401409, and 401416 Additional lots manufactured from 11/26/12 to 12/07/12 had a stop ship issued issued on 11/21/12 and the product was placed in quarantine (it was not distributed). This represents an additional 175 units from a total of 187 units manufactured during this time period. 12 units were used for bench testing. The lot numbers of units in quarantine are 401432, 401434, 401436, and 401441.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including NC, VA, WI, TN, KY, IN, FL, MI, IA, IL, TX, LA, AR, HI, CA, NV, OR, and WA,
  • 제품 설명
    EndoGastric Solutions EsophyX2 Plus Device with Serosa Fastener and Accessories Part number C02033-01. Label reads in part "EsophyX2 2-LINK Device Qty: (1) Fastener Delivery System ***" || Designed for the treatment of Gastroesophageal Reflux Disease (GERD), with erosive and non-erosive esophagitis
  • Manufacturer
    Endogastric Solutions Inc

Manufacturer

Endogastric Solutions Inc
  • 제조사 주소
    Endogastric Solutions Inc, 8210 154th Ave NE, Redmond WA 98052-3877
  • 제조사 모회사 (2017)
    Endogastric Solutions Inc
  • Source
    USFDA