BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION CLIP DEVICE

    MDR report key: 1203191 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05385
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS INFORMED THAT DURING A HEMOSTASE PROCEDURE, AFTER CLIPPING AND REMOVING THE RESOLUTION CLIPPING DEVICE SYSTEM, THE CLIP AUTOMATICALLY OPENED. AS A RESULT, THE CLIP WAS NOT IN THE PLACE OF THE BLEEDING. THIS HAPPENED WITH THREE ADDITIONAL RESOLUTION CLIPPING DEVICES BEFORE THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A DIFFERENT DEVICE. PATIENT IS "OK". NOTE: THIS COMPLAINT IS THE FIRST OF FOUR DEVICES. REFER TO MFR #'S 3005099803-2008-05382, 3005099803-2008-05383, 3005099803-2008-05384, FOR THE OTHER THREE RELATED REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION CLIP DEVICE MND BOSTON SCIENTIFIC CORPORATION M00522611 0ML8062501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK