BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1020612 · Received March 28, 2008

    Report

    Report Number
    1222780-2008-00025
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE IFU UNDER THE WARNINGS SECTION: USE CAUTION NOT TO PERFORATE THE UTERINE WALL WHEN SOUNDING, DILATING, OR INSERTING THE DISPOSABLE DEVICE. IF THE DISPOSABLE DEVICE IS DIFFICULT TO INSERT INTO THE CERVICAL CANAL, USE CLINICAL JUDGEMENT TO DETERMINE WHETHER OR NOT FURTHER DILATION IS REQUIRED. THE NOVASURE SYSTEM PERFORMS A CAVITY INTEGRITY ASSESSMENT (CIA) TEST TO EVALUATE THE INTEGRITY OF THE UTERINE CAVITY, AND SOUNDS AN ALARM WARNING OF A POSSIBLE PERFORATION PRIOR TO TREATMENT. (STEP 2.36). ALTHOUGH DESIGNED TO DETECT A PERFORATION OF THE UTERINE WALL IT (CIA ALARM) IS AN INDICATOR ONLY AND IT MIGHT NOT DETECT ALL PERFORATIONS UNDER ALL POSSIBLE CIRCUMSTANCES. CLINICAL JUDGEMENT MUST ALWAYS BE USED. ACCORDING TO THE IFU UNDER THE PRECAUTIONS SECTION: THE SAFETY AND EFFECTIVENESS OF THE NOVASURE SYSTEM HAS NOT BEEN FULLY EVALUATED IN PTS WHO HAVE UNDERGONE A PREVIOUS ENDOMETRIAL ABLATION.

    Description of Event or Problem · 1

    USER FACILITY REPORTED PHYSICIAN HAD DIFFICULTY SEATING TWO DISPOSABLE NOVASURE DEVICES. THE ELECTRODE ARRAY POSITION (EAP) LIGHT REMAINED ILLUMINATED AND THE ABLATION CYCLE WOULD NOT BEGIN. THE PHYSICIAN ABORTED THE PROCEDURE AND FOUND A UTERINE PERFORATION ON HYSTEROSCOPY. NO SUTURES WERE NEEDED FOR THE PERFORATION AND THE PT WAS DISCHARGED FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM RADIO FREQUENCY ENDOMETRIAL ABLATION MNB CYTYC SURGICAL PRODUCTS NS2000 07D17H

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other