BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE

    MDR report key: 3021246 · Received March 21, 2013

    Report

    Report Number
    3021246
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 22, 2013
    Manufacturer
    US ENDOSCOPY GROUP, INC.
    Product Code
    KNS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR AN EGD/GI AND COLONOSCOPY, TRACT CAPSULE. THE CAPSULE DELIVERY DEVICE AND PILL WAS PREPARED CORRECTLY AND PLACED INTO PATIENT. WHEN THE NURSE TRIED TO DEPLOY THE CAPSULE DELIVERY DEVICE, THE GI PILL WOULD NOT DETACH FROM THE DELIVERY DEVICE. ALL EQUIPMENT WAS TAKEN OUT OF THE PATIENT AND STEPS WERE REPEATED. THE SECOND ATTEMPT WITH A NEW CAPSULE DELIVERY DEVICE FAILED ALSO.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EGD/GI AND COLONOSCOPY, TRACT CAPSULE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117486 ADVANCE ENDOSCOPE AND/OR ACCESSORIES KNS US ENDOSCOPY GROUP, INC. 00711144 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR