BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1213858 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05413
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS INFORMED THAT AFTER A POLYP REMOVAL LOCATED IN THE RECTUM, PHYSICIAN WANTED TO CLIP AREA DUE TO A WIDE OPENING. EIGHT OR NINE RESOLUTION CLIP DEVICES WERE NEEDED TO BE USED. DURING PROCEDURE, FOUR OF THE RESOLUTION CLIP DEVICES BEING USED SNAPPED OPEN. ONE SIDE, EDGE OF THE CLIP(S) BENT IN THE OPPOSITE DIRECTION; THE TIP(S) HAD OPENED INSTEAD TO "CLOSE TO SNAP". THE CLIPS WERE REPLACED WITH OTHER FOUR OF THE SAME, AND PROCEDURE WAS COMPLETED WITHOUT PT COMPLICATIONS. PT IS "OK". NOTE: THIS IS THE FOURTH COMPLAINT OF FOUR DEVICES USED IN SAME PROCEDURE. REFER TO MFR'S 3005099803-2008-05412, 3005099803-2008-05415, 3005099803-2008-05414 FOR OTHER THREE RELATED REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522610 0ML8052008

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR