BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1001092 · Received February 22, 2008

    Report

    Report Number
    1222780-2008-00014
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 21, 2008
    Report Date
    January 23, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER REVEALED NO ABNORMALITIES RELATED TO THE REPORTED INFO. THIS DEVICE PASSED FINAL TESTING PRIOR TO RELEASE. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED; THEREFORE, AN INVESTIGATION WAS UNABLE TO BE PERFORMED. ACCORDING TO THE IFU UNDER THE WARNINGS SECTION: USE CAUTION NOT TO PERFORATE THE UTERINE WALL WHEN SOUNDING, DILATING , OR INSERTING THE DISPOSABLE DEVICE. IF THE DISPOSABLE DEVICE IS DIFFICULT TO INSERT INTO THE CERVICAL CANAL, USE CLINICAL JUDGEMENT TO DETERMINE WHETHER OR NOT FURTHER DILATION IS REQUIRED. THE NOVASURE SYSTEM PERFORMS A CAVITY INTEGRITY ASSESSMENT (CIA) TEST TO EVALUATE THE INTEGRITY OF THE UTERINE CAVITY, AND SOUNDS AN ALARM WARNING OF A POSSIBLE PERFORATION PRIOR TO TREATMENT. (STEP 2.36). ALTHOUGH DESIGNED TO DETECT A PERFORATION OF THE UTERINE WALL, IT (CIA ALARM) IS AN INDICATOR ONLY AND IT MIGHT NOT DETECT ALL PERFORATIONS UNDER ALL POSSIBLE CIRCUMSTANCES. CLINICAL JUDGEMENT MUST ALWAYS BE USED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED THAT DURING A NOVASURE PROCEDURE, THE DOCTOR FELT A "GIVE" WITH THE FIRST DISPOSABLE NOVASURE DEVICE. THE PHYSICIAN ATTEMPTED TO COMPLETE THE ABLATION WITH A SECOND DEVICE. THE CAVITY INTEGRITY ASSESSMENT TEST WAS UNSUCCESSFUL WITH BOTH DEVICES. DURING LAPAROSCOPY, TWO UTERINE PERFORATIONS WERE NOTED AT THE FUNDUS. NO TREATMENT WAS NEEDED AND THE PT WAS DISCHARGED HOME. IN 2008, THE PHYSICIAN REPORTED THE PT HAS BEEN SEEN ON FOLLOW-UP AND IS DOING FINE.

    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 07H30HC

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other