BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE CAPSULE DELIVERY DEVICE

    MDR report key: 4804199 · Received May 26, 2015

    Report

    Report Number
    4804199
    Event Type
    Malfunction
    Date Received
    May 26, 2015
    Date of Event
    March 6, 2015
    Report Date
    May 14, 2015
    Manufacturer
    US ENDOSCOPY GROUP, INC.
    Product Code
    KOG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS HAVING AN EGD WITH CAPSULE INSERTION. THE SCOPE WAS REMOVED FROM THE PATIENT TO APPLY THE CAPSULE. WHEN WE TRIED TO PASS THE DELIVERY DEVICE DOWN THE PORT, THE YELLOW PROTECTIVE CAP FOR END OF DEVICE BENT. THE YELLOW COVER BENT SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340446 ADVANCE CAPSULE DELIVERY DEVICE ENDOSCOPE AND/OR ACCESSORIES KOG US ENDOSCOPY GROUP, INC. * 1500124

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR