BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILITATION SYSTEM

    MDR report key: 1709430 · Received June 3, 2010

    Report

    Report Number
    3005099803-2010-02352
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    December 30, 2009
    Report Date
    May 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE, A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS SENT TO SANMINA FOR ANALYSIS. EVALUATION RESULTS STATE THE RF FAILED DUE TO A LOOSE GROUND WIRE. IN ADDITION, THE HARD DRIVE CRASHED. THE UNIT ALSO HAD A DAMAGED MOUNTING BASE AND A DAMAGED EXTERIOR PANEL. THE MALFUNCTIONS WERE ADDRESSED BY REPLACING THE DAMAGED EXTERIOR PANEL AND MOUNTING BASE, LOOSE GROUND WIRE AT THE FRAME AND THE HARD DRIVE. ONCE SANMINA REPLACED THE DAMAGED COMPONENTS AND PERFORMED ALL NEEDED UP GRADES, THE CONSOLE PASSED ALL TESTS AND BURN IN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS USED DURING A BENIGN PROSTATIC HYPERPLASIA (BPH) PROCEDURE. THE PATIENT AGE WAS REPORTED AS OVER (B)(6). A SURGICAL TECHNICIAN FROM THE (B)(6) UNIT CALLED INTO TECHNICAL SERVICES DURING THE TREATMENT TO REPORT THE FOLLOWING PROBLEMS WITH PROLIEVE UNIT: THE CONSOLE DID NOT HEAT THE WATER FOR THE TRANSURETHRAL CATHETER, AN ERROR MESSAGE OF "HEAT EXCHANGER (HXC) PLATES NOT WORKING, TREATMENT WILL NOW STOP" WAS DISPLAYED AND THE LCD VIDEO DISPLAY ADJUSTABLE SUPPORT WAS PHYSICALLY BROKEN. NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR-REPORTABLE SCENARIO. HOWEVER, EVALUATION OF THE RETURNED CONSOLE REVEALED AN MDR-REPORTABLE MALFUNCTION OF RADIO FREQUENCY (RF) OUT OF SPECIFICATION. THE MDR IS BASED ON THE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILITATION SYSTEM SYSTEM, HYPERTHERMIA, RF/MICROWAVE (BENIGN PROSTATIC HYPERPLASIA),THERMOTHERAPY MEQ BOSTON SCIENTIFIC - MARLBOROUGH M006880806R0

    Patients

    Seq Age Sex Outcome Treatment
    1