BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 3062651 · Received April 17, 2013

    Report

    Report Number
    3005099803-2013-02465
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM WAS BEING SET UP FOR USE IN A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2013. THE PATIENT IS REPORTED TO BE FEMALE AND OVER 18 (NO ADDITIONAL PATIENT DETAILS AVAILABLE). ACCORDING TO THE COMPLAINANT, AFTER THE PRIMING PHASE WAS COMPLETED THE GENESYS SCREEN ADVANCED DIRECTLY TO ABLATION PREPARATION. AT THIS TIME, THE PATIENT WAS NOT IN THE ROOM SO THE NURSE POWERED DOWN THE MACHINE. UPON POWER UP, A CASSETTE DETECTED ERROR MESSAGE APPEARED. A SECOND PROCEDURE SET WAS INSTALLED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS REPORTED TO BE "FINE" AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166108 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB M006580010

    Patients

    Seq Age Sex Outcome Treatment
    1