BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1062051 · Received June 13, 2008

    Report

    Report Number
    3005099803-2008-00731
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 13, 2008
    Report Date
    May 14, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXC
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED; THEREFORE, THE CAUSE OF DETACHMENT IS UNDETERMINED. THE APRIL 2008 15 MONTH COMPLAINT TREND REPORT FOR THE HEMOSTATIC CLIPPING PRODUCT FAMILY INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO ADVERSE TRENDS WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING A POLYPECTOMY PROCEDURE ON A PATIENT IN 2008. ACCORDING TO THE COMPLAINANT, "THEY OPENED THE PACKAGE AND ADVANCED THE CLIP AND IT FELL OFF OF THE CATHETER". THE PROCEDURE WAS COMPLETED WITH ANOTHER RESOLUTION CLIP AND THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR