BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESYS HTA PROCERVA PROCEDURE SET

    MDR report key: 3232382 · Received June 12, 2013

    Report

    Report Number
    3232382
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    November 15, 2012
    Report Date
    June 12, 2013
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    HTA MACHINE WOULD NOT PROCEED TO ABLATION DESPITE NUMEROUS ATTEMPTS AND CHECKS OF EQUIPMENT SEAL AND HEIGHT. ATTEMPTED NOVASURE ABLATION - ONLY ABLE TO PARTIALLY ABLATE CAVITY. CHANGED TO THERMAL BALLOON WHICH FINISHED SUCCESSFULLY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?HYSTEROSCOPY, D&C, ENDOMETRIAL ABLATION, LAPAROSCOPY, BILATERAL TUBAL LIGATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266213 GENESYS HTA PROCERVA PROCEDURE SET DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR