Events

OLYMPUS ENDOEYE HD II Video Telescope 에 대한 현장 안전성 서한

Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는 Slovenia 에서 OLYMPUS 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 국가
    Slovenia
  • 사례 출처
    AMPMDRS
  • 비고 / 경고
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • 데이터 추가 비고
  • 원인
    Olympus has initiated this removal action following a complaint of a damaged temperature sensor at the endoeye tip which caused the distal end to become abnormally hot. although no patient or user injury occurred as a result of this reported complaint, excessive heating of the endoeye distal end could result in patient or user injury. in an effort to prevent a potential risk to patient or user health, olympus is undertaking this action to remove the model and serial numbers identified above and to repair and return the devices. the repair to correct this problem will not be available until january 2016. however, we are requiring the return of your affected devices now so as to disable a feature on the video telescopes (“fog free”) which will prevent excessive heating of the endoeye distal end. once the repair parts are available in january 2016, we will contact you again for return of your devices for the permanent corrective action. .

Device

OLYMPUS ENDOEYE HD II Video Telescope
  • 모델명 / 제조번호(시리얼번호)
    WA50040A, WA50042A
  • Manufacturer
    OLYMPUS

Manufacturer

OLYMPUS