Events

Use of Tristel Trio Wipes System with GE TEE probe 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 GE Healthcare 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-00114-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00114-1
  • 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 tristel trio wipes system has been validated for efficacy and residual toxicity for tee probes that do not have visible signs of wear or damage, and when used in connection with shorter procedure times such as cardiac scans. further testing has identified a need for clarification of the previously communicated disinfection guidance for ge tee probes regarding use of the tristel trio wipes system. specifically, in-use experience and limited testing has revealed that the previously communicated disinfection methods using tristel trio wipes may not always be effective when used in connection with procedures that have long tee probe intubation times, such as cardiac surgeries, and/or with tee probes with visible signs of wear or damage in areas to be disinfected, both of which may increase the bioburden on the probe. ge recommends the additional use of a sterile sheath covering the tee probe when tristel trio wipes are being used as the sole method of disinfection.
  • 조치
    Under conditions where the TEE probe has a long intubation time or shows visible signs of wear and damage, GE recommends the use of a sterile sheath covering the TEE probe in addition to disinfection using the Tristel Trio Wipes System.

Device

Use of Tristel Trio Wipes System with GE TEE probe
  • 모델명 / 제조번호(시리얼번호)
    Use of Tristel Trio Wipes System with GE TEE probeAffected Product: TEE probe models: 6VT-D, 6Tc, 6Tc-RS, 6T, 6T-RS, 9T and 9T-RSMultiple affected probe types and part numbersARTG Number:123916(GE Medical Systems Australia - Transducer assembly, ultrasound, diagnostic, intracorporeal, oesophageal)
  • Manufacturer
    GE Healthcare Australia Pty Ltd

Manufacturer

GE Healthcare Australia Pty Ltd