BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 892709 · Received August 9, 2007

    Report

    Report Number
    1222780-2007-00013
    Event Type
    Injury
    Date Received
    August 9, 2007
    Date of Event
    June 21, 2007
    Report Date
    July 11, 2007
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 INFO COULD BE OBTAINED; THUS NO CONCLUSION CAN BE DRAWN FOR THIS EVENT.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT A COUPLE DAYS AFTER A UNEVENTFUL UTERINE ABLATION USING THE NOVASURE SYSTEM, THE PT COMPLAINED OF PAIN. ANTIBIOTIC TREATMENT GIVEN FOR A SUSPECTED INFECTION. TWO WEEKS LATER, A LAPAROSCOPY WAS PERFORMED FOR CONTINUED PAIN AND A BURN WAS OBSERVED ON THE OUTSIDE OF THE UTERUS AS WELL AS A PORTION OF THE BOWEL. A BOWEL RESECTION WAS PERFORMED AND THE PT IS REPORTEDLY DOING WELL.

    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 Required Intervention