BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1122362 · Received August 15, 2008

    Report

    Report Number
    1222780-2008-00087
    Event Type
    Other
    Date Received
    August 15, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 17, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER REVEALED NO ABNORMALITIES RELATED TO THE REPORTED INFORMATION. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. 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): CORRECT DETERMINATION OF THE CAVITY LENGTH IS IMPORTANT FOR SAFE AND EFFECTIVE TREATMENT. OVERESTIMATING THE CAVITY LENGTH MAY RESULT IN THERMAL INJURY TO THE ENDOCERVICAL CANAL. (B) (4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT FOLLOWING A NOVASURE PROCEDURE, "2/3 OF THE CERVIX WAS NOTED TO BE ABLATED." IT WAS ADDITIONALLY REPORTED THAT THE "PATIENT HAS A LONGER THAN USUAL CERVICAL CANAL." ON (B) (6) 2008 ADDITIONAL INFORMATION INDICATED THE CERVICAL ABLATION WAS CONFIRMED ON POST PROCEDURE HYSTERECTOMY AND THAT NO TREATMENT WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB CYTYC SURGICAL PRODUCTS NS2000 08C15HA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other