BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1574939 · Received January 7, 2010

    Report

    Report Number
    1222780-2010-00001
    Event Type
    Other
    Date Received
    January 7, 2010
    Date of Event
    December 7, 2009
    Report Date
    December 8, 2009
    Manufacturer
    HOLOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER (RFC) AS PRODUCT IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. (B) (4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT FOLLOWING A NOVASURE ENDOMETRIAL ABLATION, THE PHYSICIAN DID A HYSTEROSCOPY AND VERIFIED GOOD ABLATION RESULTS. A LAPAROSCOPY WAS THEN DONE TO PERFORM A SCHEDULED TUBAL LIGATION. AT THIS TIME HE NOTICED BLANCHING ON THE FUNDUS OF THE UTERUS. THE BLANCHING "WAS ONLY TO THE UTERUS AND NOT THE ABDOMEN". THE PHYSICIAN "SEARCHED AND FOUND NO EVIDENCE OF INJURY IN THE ABDOMINAL CAVITY". NO UTERINE PERFORATION WAS SEEN ON HYSTEROSCOPY OR LAPAROSCOPY. DURING F/U ON (B) (6) 2009, IT WAS REPORTED THAT THE PT WAS DISCHARGED HOME FOLLOWING THE NOVASURE PROCEDURE, WITH A PRESCRIPTION FOR AUGMENTIN (AMOXICILLIN AND CLAVULANATE POTASSIUM, DOSE UNK) FOR 1 WEEK. DURING F/U ON (B) (6) 2009, THE PHYSICIAN REPORTED THE PT IS CURRENTLY "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOLOGIC NS2000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other RADIO FREQUENCY CONTROLLER -SERIAL # UNK