BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1193343 · Received October 7, 2008

    Report

    Report Number
    3005099803-2008-05102
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER IS UNAVAILABLE; THEREFORE, MANUFACTURER AND EXPIRATION DATE CANNOT BE CONFIRMED.

    Description of Event or Problem · 1

    IN 2008, BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A PROCEDURE TO STOP BLEEDING IN THE COLON, THE USER WAS UNABLE TO RELEASE THE RESOLUTION CLIP DEVICE'S CLIP AND IT WAS STILL ATTACHED TO THE "SHAFT". THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PT COMPLICATIONS. PT IS IN "GOOD" CONDITION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK