BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROLIEVE THERMODILATATION SYSTEM, REFURBISHED

    MDR report key: 1557321 · Received November 25, 2009

    Report

    Report Number
    3005099803-2009-05611
    Event Type
    Malfunction
    Date Received
    November 25, 2009
    Date of Event
    June 24, 2009
    Report Date
    November 3, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MEQ
    PMA / PMN Number
    P030006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE, A PROLIEVE THERMODILATATION SYSTEM, REFURBISHED, WAS SENT TO SANMINA FOR ANALYSIS. INITIAL RESULTS FROM MECHANICAL TESTING (POST BURN-IN TEST) SHOWED FAILURES OF THE THERMOELECTRIC MODULE, PHYSITEMP MODULE TEMPERATURE SENSOR #4, RF OUTPUT POWER, PUMP TEST AND PRESSURE TEST. THE RF OUTPUT, PUMP AND PRESSURE TESTS FAILED DUE TO DEFECTIVE WATCHDOG BOARD. THE MALFUNCTIONS WERE ADDRESSED BY REPLACING BOTH THE DEFECTIVE WATCHDOG TIMER BOARD AND DEFECTIVE PHYSITEMP #4 SENSOR. THE UNIT PERFORMED AND PASSED FULL TESTING AFTER DEFECTIVE COMPONENTS WERE REPLACED AND REPAIRED/ UPGRADED. (B)(4).

    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. REPORTEDLY, THE ERROR "FORWARD POWER DOES NOT CORRESPOND TO SET POWER" OCCURRED DURING BOOT UP. THE BSC SURGICAL TECHNICIAN REBOOTED AND THE ISSUE TEMPORARILY RESOLVED. THE TECH INDICATED HE CANNOT HEAR THE RF GENERATOR TURN ON. THE CASE WAS COMPLETED WITH ANOTHER UNIT. THERE WERE NO COMPLICATIONS TO THE PT. F/U WITH THE COMPLAINANT REVEALED THAT PT IS FINE. NOTE: THE EVENT, AS REPORTED, DID NOT REFLECT AN MDR- REPORTABLE SCENARIO. HOWEVER, EVAL OF THE RETURNED CONSOLE REVEALED AN MDR-REPORTABLE MALFUNCTION OF "FAILED RF OUTPUT TEST" . THE MDR IS BASED UPON THE EVAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIEVE THERMODILATATION SYSTEM, REFURBISHED MEQ BOSTON SCIENTIFIC CORPORATION M006880806R0

    Patients

    Seq Age Sex Outcome Treatment
    1