BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19218374 · Received April 30, 2024

    Report

    Report Number
    9610595-2024-08963
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 16, 2024
    Report Date
    May 22, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ONGOING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE FLEX VIDEO SCOPE AIR/WATER CHANNEL HAD WHITE CRYSTALLIZED CONTAMINATION. THERE WERE NO REPORTS OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155774 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown