BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 932094 · Received October 24, 2007

    Report

    Report Number
    1222780-2007-00039
    Event Type
    Injury
    Date Received
    October 24, 2007
    Date of Event
    September 21, 2007
    Report Date
    September 24, 2007
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED TO CYTYC SURGICAL PRODUCTS, THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. BECAUSE THE LOT NUMBER WAS NOT PROVIDED, AN INVESTIGATION OR REVIEW OF THE DEVICE HISTORY RECORD FOR THE DEVICE WAS NOT ABLE TO BE PERFORMED. NO FURTHER INFORMATION COULD BE OBTAINED; THUS NO CONCLUSION CAN BE DRAWN FOR THIS EVENT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT 24 HOURS AFTER UNEVENTFUL UTERINE ABLATION USING THE NOVASURE SYSTEM, THE PATIENT PRESENTED WITH A SEVERE ABDOMINAL PAIN AND VOMITING. A LAPAROSCOPIC PROCEDURE WAS PERFORMED WITH NO EVIDENCE OF BOWEL BURN AND THE UTERINE CAVITY APPEARED AS EXPECTED FOLLOWING A UTERINE ABLATION. IV ANTIBIOTICS WERE GIVEN FOR A DIAGNOSIS OF SEVERE ENDOMETRITIS. THE PATIENT RESPONDED WELL TO THE TREATMENT.

    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 YR Other