Events

EVOTECH Endoscope Cleaner and Reprocessor (ECR) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd 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
    RC-2015-RN-00432-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2015-05-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00432-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The evotech endoscope cleaner and reprocessor (ecr) may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. the likelihood of this occurrence is low, and asp has not received complaints or reports of adverse events related to this issue.The evotech ecr is designed to verify endoscope connections for each cycle. if an improper connection is detected, the system is designed to stop and cancel the cycle. this system detection, along with a user verification step stated in the user’s guide to verify the connections of the endoscope channels before and after the completion of a cycle, help to ensure that an endoscope has been processed properly.As a result sites may need to manually process endoscopes which may increase processing time. an accumulation of processing time may result in surgical delay or rescheduling patients.
  • 조치
    A workaround is provided via the Customer Letter whilst a permanent fix is developed. This action has been closed-out on 03/03/2016.

Device

EVOTECH Endoscope Cleaner and Reprocessor (ECR)
  • 모델명 / 제조번호(시리얼번호)
    EVOTECH Endoscope Cleaner and Reprocessor (ECR)Part numbers: 50004 and 50004-002ARTG number: 146438
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd