BEUDAMED
    FDA Adverse Event Summary report: N

    HOLOGIC

    MDR report key: 3010679 · Received March 13, 2013

    Report

    Report Number
    MW5029370
    Date Received
    March 13, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 4, 2013
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    (B)(6) FEMALE WITH HISTORY OF MENORRHAGIA UNDERWENT A D&C AND NOVASURE ABLATION. DURING THE PHYSICIAN INDICATED THAT "THE NOVASURE CAVITY ASSESSMENT HAD THE MACHINE SET AT 3.2 CM AND 5.5 CM LENGTH AND 3.2 FOR WIDTH". "DURING THE CAVITY ASSESSMENT PORTION OF PROCEDURE, THE WIDTH SUDDENLY JUMPED TO 4.5CM WIDTH." "THE SPRING LOADED PORTION OF THE ARRAY HAD POPPED OPEN MUCH FURTHER AND SUDDENLY MACHINE BEGAN TO SUCTION MORE FLUID". THE ENDOMETRIAL ARRAY WAS REMOVED. THE HYSTEROSCOPE WAS RE-INSERTED AND IT WAS NOTED THAT THE "ARRAY HAD POPPED OPEN FURTHER DAMAGING THE UTERUS AND UTERINE PERFORATION." AT THAT TIME, IT WAS DECIDED TO CONVERT THE PROCEDURE TO A DIAGNOSTIC LAPAROSCOPY (FROM THE INTENDED VAGINAL PROCEDURE) TO "CAUTERIZE THE SMALL SITES THAT WERE BARELY BLEEDING". PT WAS TRANSPORTED TO RECOVERY ROOM IN STABLE CONDITION. POST RECOVERY ROOM, PT WAS DISCHARGED HOME PER W/C IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106172 HOLOGIC NOVASURE (ENDOMETRIAL ABLATION SYSTEM) MNB NS2000 12K17R

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention