Events

Device Recall EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Olympus America 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
    70858
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2807-2015
  • 사례 시작날짜
    2015-03-26
  • 사례 출판 날짜
    2015-09-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-02-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135241
  • 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
    duodenoscope and accessories, flexible/rigid - Product Code FDT
  • 원인
    New and validated reprocessing procedures have been issued for the olympus tjf-q180v duodenoscope ("tjf-q180v"), consisting of revised manual cleaning and high level disinfection procedures.
  • 조치
    The firm, Olympus, sent an "Urgent Safety Notification" dated March 26, 2015, to direct consignees/customers. The notification described the product, problem and actions to be taken. The notification contained new reprocessing procedures. The customers were instructed to immediately implement new precleaning and high level disinfection procedure; ensure that all personnel involved in the reprocessing are completely knowledgeable and thoroughly trained on the new reprocessing instructions; complete and return the enclosed questionnaire via fax to (484) 896-7128 and implement the new cleaning instructions when the new brushes arrive on/about May 8, 2015. If you have question, contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, Monday-Friday between 7 AM EST - 8 PM EST. For additional information on this matter, contact V.P., Regulatory/Clinical Affairs & Quality Assurance at (484) 896-5688 or by email at laura.storms@olympus.com.

Device

Device Recall EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V
  • 모델명 / 제조번호(시리얼번호)
    Model: TJF-Q180V, all sold units
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: Canada and Mexico.
  • 제품 설명
    EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. || This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
  • Manufacturer
    Olympus America Inc.

Manufacturer

Olympus America Inc.
  • 제조사 주소
    Olympus America Inc., 3500 Corporate Pkwy., P.O. Box 610, Center Valley PA 18034-0610
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA