BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1220299 · Received November 3, 2008

    Report

    Report Number
    3005099803-2008-05760
    Event Type
    Malfunction
    Date Received
    November 3, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON OCTOBER 6, 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT WHEN THE USER TRIED TO ADVANCE THE RESOLUTION CLIP DEVICE, IT DID NOT GRASP THE "PLASTIC PIECE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8061106

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK