Events

Classic Series Reusable Active Cord Designed to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generators 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-2018-RN-00326-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-04-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00326-1
  • 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 has been made aware by the manufacturer, gyrus acmi, of an issue with the c650-129a classic series reusable cord whereby the cord may become damaged and potentially trigger sparks during use. in the event that cord is damaged, it may short circuit and pose risk of minor electrical shock/burn to the user or patient. if the shorting cable comes in to contact with flammable material there is a risk of fire in the operating room.Investigation of this issue revealed that due to the configuration and location of the cable, the problem could result from users pulling on the cable as opposed to the connector when unplugging the cable. olympus recommends that cables are unplugged by grasping the plug and not by pulling on the cable. to date, there have been no reports of patient injury or death as a result of this issue.Olympus australia has ceased supply of the c650-129a classic series reusable active cord since november 2013.
  • 조치
    Olympus is advising users to inspect inventory for any C650-129A Classic Series Reusable Active Cords, cease use and dispose of them accordingly.

Device

Classic Series Reusable Active Cord Designed to be used with Gyrus ACMI FOCUS 640, Bovie and othe...
  • 모델명 / 제조번호(시리얼번호)
    Classic Series Reusable Active CordDesigned to be used with Gyrus ACMI FOCUS 640, Bovie and other general purpose monopolar electrosurgical generatorsModel Number: C650-129AAll Serial NumbersARTG Number:137430(Olympus Australia - Cable/lead, electrosurgical unit)
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd