BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON-SCIENTIFIC

    MDR report key: 902263 · Received August 20, 2007

    Report

    Report Number
    MW5003509
    Event Type
    Other
    Date Received
    August 20, 2007
    Date of Event
    June 26, 2007
    Report Date
    August 20, 2007
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED SECOND DEGREE VAGINAL BURN POST-HYDROTHERMAL ABLATION DUE TO EQUIPMENT POWER FAILURE DURING PROCEDURE. THE MACHINE HAD BEEN PLUGGED INTO A POWER STRIP ON THE MONITOR TOWER RATHER THAN INTO A WALL SOCKET. THIS CAUSED THE MACHINE TO POWER DOWN DURING THE BEGINNING OF THE "HEAT UP" PORTION OF THE PROCEDURE. MACHINES WERE SEPARATED AT THAT TIME AND RESTARTED PROMPTLY. THE POWER DOWN INCIDENT CAUSED HOT FLUID TO LEAK OUT OF THE MACHINE INTO THE PT'S VAGINA CAUSING THE ABOVE DESCRIBED BURNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON-SCIENTIFIC HYDRO-THERMABLATION UNIT MNB BOSTON SCIENTIFIC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other