Events

Device Recall OERPro Endoscope Reprocessor 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
    74542
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0138-2017
  • 사례 시작날짜
    2016-06-23
  • 사례 출판 날짜
    2016-10-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147873
  • 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
    Accessories, cleaning, for endoscope - Product Code FEB
  • 원인
    New warning requiring users to conduct duodenoscope precleaning and manual cleaning even when using an automated endoscope reprocessor (aer) that has instructions that may indicate a user could forego certain steps in precleaning and manual cleaning of the endoscopes.
  • 조치
    Olympus America Inc. (OAI) mailed a letter to customers informing them that they are issuing an updated Operation Manual for the OER-Pro Automated Endoscope Reprocessor. The following actions were asked to be taken: -Olympus has discontinued previously distributed copies of the OER-Pro Operation Manual. - Inspect your inventory of Operation Manuals and discard any existing inventory of OER-Pro Operation Manuals. - Implement use of the enclosed OER-Pro Operation Manual, which contains the new Warning on pages 73 and 80. - Ensure all reprocessing personnel are completely knowledgeable and thoroughly trained on the requirement to perform precleaning and manual cleaning of Olympus duodenoscopes prior to placing the duodenoscopes in the OER-Pro for high level disinfection. - Additional copies of the new OER-Pro Operation Manual can be obtained by contacting our Technical Assistance Center at 1-800-848-9024, option 1, or by indicating on the enclosed questionnaire. Additional Operation Manuals will be mailed to your facility - Please indicate on the enclosed questionnaire that you have received this notification. Fax the completed form to (484) 896-7128.

Device

Device Recall OERPro Endoscope Reprocessor
  • 모델명 / 제조번호(시리얼번호)
    Model: OER-Pro, All serial numbers affected
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to: AK,AL,AR,AZ,CA,CO,CT,DC,DE,FL,GA,HI,IA,ID,IL,IN,KS,KY,LA,MA,MD,ME,MI,MN,MO,MS,MT,NC,ND,NE,NH,NJ,NM,NV,NY,OH,OK,OR,PA,RI,SC,TN,TX,UT,VA,VT,WA,WI,WV,WY
  • 제품 설명
    OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
  • 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