Events

Device Recall EVIS EXERA Duodenovideoscope OLYMPUS TJF 160F/VF 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Olympus Corporation of the Americas 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
    73640
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1845-2016
  • 사례 시작날짜
    2016-03-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-02-06
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144647
  • 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 reprocessing instructions for the olympus tjf-160/vf duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (maj-1534), which is enclosed with the notification.
  • 조치
    Olympus notified customers on 03/14/2016 via an Urgent Safety Notification letter that referenced discontinuation of previously distributed copies of the TJF-160F/VF Reprocessing Manual. Customers were asked to inspect their inventory and discard any existing inventory of TJF-160F/VF Reprocessing Manuals. They were asked to update their information with the enclosed TJF-160F/VF Reprocessing Manual, which contains new brushing and flushing steps for the TJF-160F/VF elevator mechanisms and the forceps elevator recesses. Instuctions for cleaning and a new cleaning brush (used for cleaning the device) was included with the notification. Customers were asked to ensure all reprocessing personnel are completely knowledgeable and throughly training on the new reprocessing instructions in the new Reprocessing Manual.

Device

Device Recall EVIS EXERA Duodenovideoscope OLYMPUS TJF 160F/VF
  • 모델명 / 제조번호(시리얼번호)
    Models: TJF-160F and TJF-160VF, all serial numbers
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide:
  • 제품 설명
    EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF || used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
  • Manufacturer
    Olympus Corporation of the Americas

Manufacturer

Olympus Corporation of the Americas
  • 제조사 주소
    Olympus Corporation of the Americas, 3500 Corporate Pkwy, PO Box 610, Center Valley PA 18034-0610
  • 제조사 모회사 (2017)
    Olympus Corporation
  • Source
    USFDA