BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

    MDR report key: 19392237 · Received May 24, 2024

    Report

    Report Number
    9610595-2024-10557
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 26, 2024
    Report Date
    June 24, 2024
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FDS
    UDI-DI
    04953170305276
    PMA / PMN Number
    K131780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED WHITISH FOREIGN MATERIAL IN THE PLASTIC DISTAL END COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333338 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE GASTROINTESTINAL VIDEOSCOPE FDS AIZU OLYMPUS CO., LTD. GIF-HQ190 04953170305276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown