BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVASURE ABLATION SYSTEM

    MDR report key: 1242123 · Received November 24, 2008

    Report

    Report Number
    1242123
    Event Type
    Malfunction
    Date Received
    November 24, 2008
    Date of Event
    October 15, 2008
    Report Date
    November 24, 2008
    Manufacturer
    CYTEC SURGICAL SERVICES, INC.
    Product Code
    MNB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OPERATIVE PROCEDURE: PAP SMEAR, EXAMINATION UNDER ANESTHESIA, HYSTEROSCOPY, FRACTIONAL DILATATION AND CURETTAGE, ATTEMPTED ENDOMETRIAL POLYPECTOMY, ENDOMETRIAL ABLATION ATTEMPTED, NOT PERFORMED. MULTIPLE ATTEMPTS WERE MADE TO GRASP THE POLYP, NONE WERE SUCCESSFUL. THREE DIFFERENT POLYP EXTRACTION DEVICES WERE UTILIZED. ONE OF THESE COULD NOT BE OPENED BECAUSE OF THE MECHANICS OF THE INSTRUMENT AND THE LENGTH OF THE UTERINE CAVITY. THE OTHER TWO, HOWEVER, COULD BE ADEQUATELY MANIPULATED, HOWEVER, THE POLYP COULD NOT BE REMOVED DESPITE MULTIPLE ATTEMPTS. IT WAS FELT THAT THE BROAD BASED ATTACHMENTS OF THE POLYP MAY HAVE BEEN A CONTRIBUTING FACTOR IN THE INABILITY TO GRASP AND REMOVE THIS POLYP. THEN, USING A MEDIUM SIZE SHARP CURETTE, THE ENDOMETRIAL CAVITY WAS COMPLETELY CURETTED. A SMALL AMOUNT OF TISSUE WAS OBTAINED. THERE WAS NOTED TO BE AN IRREGULARITY IN THE CAVITY IN THE AREA OF THE SUBMUCOUS MYOMATA. FOLLOWING COMPLETE CURETTAGE, THE NOVASURE DEVICE WAS INTRODUCED INTO THE ENDOMETRIAL CAVITY. A GOOD SEAL WAS OBTAINED AT THE CERVIX. TEST OF CAVITY INTEGRITY WAS CARRIED OUT AND CAVITY INTEGRITY COULD NOT BE DEMONSTRATED DESPITE TWO ATTEMPTS. IT WAS FELT THAT THERE WAS NO PERFORATION, BUT THAT THE DEVICE COULD NOT DOCUMENT CAVITY INTEGRITY DUE TO THE LARGE SIZE OF THE ENDOMETRIAL CAVITY. BECAUSE CAVITY INTEGRITY COULD NOT BE ESTABLISHED, THE ABLATION COULD NOT BE CARRIED OUT WITH THE NOVASURE DEVICE. IT WAS FELT THAT THE CAVITY WAS ALSO TOO LARGE FOR ABLATION WITH A THERMAL BALLOON AND THEREFORE, AN ABLATION COULD NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE ABLATION SYSTEM ABLATION SYSTEM, ENDOMETRIAL MNB CYTEC SURGICAL SERVICES, INC. UNK 08B22HA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR