Events

cystoscopy bridge 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 KEYMED 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
  • 날짜
    2017-09-01
  • 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 is implementing a field safety corrective action ("fsca") of the cystoscopy bridges and the working insert referenced above. cystoscopy bridges and working inserts are used for endoscopic diagnosis and treatment in urologic applications. olympus has initiated this fsca after receiving complaints about fragments of adhesive which detached from inside the working channel of the referenced cystoscopy bridge models. cracking, chipping, missing pieces, and delamination of the adhesive have been observed. investigations have confirmed that this adhesive can detach during the intended use of the cystoscopy bridge or working insert, e.G. when inserting an instrument through the working channel. as a result, a fragment of the adhesive may fall inside the patient's bladder or urethra and will need to be retrieved. although typically flushed out with irrigation fluid or passed naturally, the retrieval of large fragments of the adhesive could require additional surgical treatment. furthermore, the procedure can be prolonged resulting in extended anesthesia. .

Device

cystoscopy bridge
  • 모델명 / 제조번호(시리얼번호)
    A20975A Working insert, with ramp, one way 13ZW, 149W, 14ZW, 159W, 15ZW, 162W, 168W A20976A Bridge, one way 146W, 147W, 148W, 149W, 14XW, 14YW, 14ZW, 151W, 152W, 153W, 154W, 155W, 156W, 157W, 158W, 159W, 15XW, 15YW, 161W, 162W, 163W, 164W, 165W, 167W, 168W, 16YW, 16ZW, 171W, 172W A20977A Bridge, two way 146W, 148W, 149W, 14XW, 14ZW, 151W, 152W, 153W, 154W, 155W, 156W, 158W, 159W, 15XW, 15YW, 161W, 162W, 163W, 164W, 165W, 166W, 167W, 168W, 169W, 16XW, 16ZW, 171W, 172W, 173W
  • Manufacturer
    OLYMPUS KEYMED

Manufacturer

OLYMPUS KEYMED