Events

Device Recall AES50S 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 ConMed Corporation 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
    71518
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0205-2016
  • 사례 시작날짜
    2015-06-17
  • 사례 출판 날짜
    2015-11-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138104
  • 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 GEI
  • 원인
    Probe programming error. the incorrect program can generate more heat at the surgical site, resulting in an elevated probability of tissue damage.
  • 조치
    On June 17, 2015 Con Med Corporation distributed Urgent Device Recall Notification Letters and Recall Reply forms to their customers via courier service. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine their inventory for any of the affected lot numbers referenced on the recall notice. If any of the recalled product are in stock, customers should discontinue the use or distribution of these items. If product was further distributed, customers should notify those individuals of this recall action. Customers with questions can call Gregory Connell at 727-399-5276 or email AES50S@conmed.com. Customers should also complete and return the Recall Reply Form by mail to the address listed on the recall notice.

Device

Device Recall AES50S
  • 모델명 / 제조번호(시리얼번호)
    1412161, 1410201, 1410271, 1412121, and 1412081
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide - US distribution in the states of FL, OH, and the country of Spain.
  • 제품 설명
    Arthroscopic Energy 50¿ Probe with Suction, Catalog number: AES-50S || Peoduct Usage: || For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic surgical procedures.
  • Manufacturer
    ConMed Corporation

Manufacturer

ConMed Corporation
  • 제조사 주소
    ConMed Corporation, 525 French Rd, Utica NY 13502-5945
  • 제조사 모회사 (2017)
    CONMED Corp.
  • Source
    USFDA