Events

ENDOEYE Video Telescope 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-2015-RN-01141-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-11-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01141-1
  • 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 backup mechanism designed to detect and identify a failed temperature sensor is not functioning as expected, resulting in the potential for excessive heating if the sensor should fail. although no patient or user injury has occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury.
  • 조치
    Olympus is advising the customers to inspect stock and quarantine the affected units prior to their return to the sponsor. Upon receiving the affected units, Olympus will perform a short term correction by disabling the "fog-free" function and return the corrected units back to the customers for routine use. A final permanent fix involving a hardware upgrade will restore full functionality of the device is expected to be performed in 2016.

Device

ENDOEYE Video Telescope
  • 모델명 / 제조번호(시리얼번호)
    ENDOEYE Video TelescopeENDOEYE 10mm 0 degreesPart #: WA50040AS/N: 622642, 622770, 622774, 622776, 623616, 623617, 623618, 623620, 624087, 624088ENDOEYE 10mm 30 degreesPart #: WA50042AS/N: 622506, 622529, 622530, 622531, 622532, 622533, 622781, 623665, 623667, 623684, 624075, 624094, 624619, 624627ENDOEYE devices repaired with affected spare partPart #: WA50040A or WA500422S/N: 616960, 616963, 617144, 617801, 619863ARTG Number: 121101
  • 의료기기 분류등급
    Obstetrical and Gynecological Devices
  • Manufacturer
    Olympus Australia Pty Ltd

Manufacturer

Olympus Australia Pty Ltd