BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1203290 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05367
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING THE COLONOSCOPY PROCEDURE, UPON DEPLOYMENT OF THE RESOLUTION CLIP, ONE ARM BENT BACKWARDS AGAINST THE MUCOSA NOT ALLOWING THE CLIP TO CLOSE PROPERLY. THE LITTLE PIECE OF THE CLIP WAS REMOVED THROUGH THE SCOPE VIA SUCTION. THE REST OF THE CLIP WAS PUSHED ASIDE WITH THE SCOPE AND LEFT IN THE PT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PT'S CONDITION IS REPORTED TO BE "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8071110

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR