BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1061973 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00707
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    GDO
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A COLONOSCOPY, THE RESOLUTION CLIP DEVICE WOULD NOT DETACH FROM THE SHEATH. THEY USED ANOTHER OF THE SAME DEVICE TO COMPLETE THE CASE. PT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE GDO BOSTON SCIENTIFIC M00522611 0ML7033103

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK