BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1063130 · Received June 20, 2008

    Report

    Report Number
    1222780-2008-00064
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE DEVICE. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) UNDER THE WARNING 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.

    Description of Event or Problem · 1

    USER FACILITY REPORTED, THEY WERE ATTEMPTING A UTERINE ABLATION WITH A DISPOSABLE NOVASURE DEVICE BUT HAD TO ABORT THE PROCEDURE DUE TO AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST. THE PHYSICIAN REMOVED THE NOVASURE DEVICE FROM THE PATIENT'S CAVITY AND PERFORMED A HYSTEROSCOPY. HE NOTED THAT THERE WAS A "VERY SMALL PERFORATION" IN THE UTERUS. THE PHYSICIAN REPAIRED THE PERFORATION WITH CAUTERIZATION AND THEN PERFORMED A TUBAL LITIGATION. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 30, 2008. THE PATIENT WAS REPORTEDLY "DOING GREAT" AFTER THE PROCEDURE AND WAS DISCHARGED FROM THE HOSPITAL IN 2008.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention