Events

HF Cable used with ESG-400 Electrosurgical Generator (bipolar) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Olympus Australia 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-2016-RN-01161-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-09-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01161-1
  • 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
    Olympus is notifying users of the reoccurrence of potential error codes for the olympus wa00014a hf cable. although procedures can continue by troubleshooting and clearing error codes in accordance with the esg-400 instructions for use (section 8.2), olympus is highlighting instances of the following error codes when the device is connected: - e618 ‘data transfer’, - e486 ‘no instrument connected’; or, - a pop up message ‘use default instrument settings’ there have been no australian reports of these error codes or incidents with patient injury worldwide. error codes typically only occur in the rare event of rapid activation, such as re-activating the esg-400 electrosurgical generator within 0.2 seconds after the last activation.
  • 조치
    Olympus is advising users that if the error occurs, to troubleshoot as per the Instructions for Use (IFU) to continue the procedure, and notify Olympus to obtain a replacement cable. This action has been closed-out on 12/05/2017.

Device

HF Cable used with ESG-400 Electrosurgical Generator (bipolar)
  • 모델명 / 제조번호(시리얼번호)
    HF Cable used with ESG-400 Electrosurgical Generator (bipolar)Product Code: WA00014A ARTG Number: 194874
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd