BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1294255 · Received January 22, 2009

    Report

    Report Number
    1222780-2009-00007
    Event Type
    Injury
    Date Received
    January 22, 2009
    Date of Event
    December 23, 2008
    Report Date
    December 23, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER (RFC) AS IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. BASED ON THE INFORMATION OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) UNDER THE WARNING 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 JUDGMENT 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. IF A UTERINE PERFORATION IS SUSPECTED, THE PROCEDURE SHOULD BE TERMINATED IMMEDIATELY. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) UNDER THE CONTRAINDICATION SECTION: IF A PERFORATION IS SUSPECTED, THE PROCEDURE SHOULD BE TERMINATED IMMEDIATELY.

    Description of Event or Problem · 1

    USER FACILITY REPORTED AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST DURING AN ATTEMPTED NOVASURE ABLATION. IT IS NOT KNOWN IF THE PHYSICIAN ATTEMPTED TO TROUBLESHOOT THE ALARM BUT THE FACILITY REPORTED THE NOVASURE PROCEDURE WAS ABANDONED. NO POST HYSTEROSCOPY WAS PERFORMED. THE PHYSICIAN DECIDED TO USE A COMPETITOR'S DEVICE DO THE UTERINE ABLATION. THE PHYSICIAN LATER REPORTED "IT APPEARS THAT ONE OF THE PRONGS ON THE OUTER EDGE OF THE NS PERFORATED THE UTERUS". IT IS NOT KNOWN IF OR WHEN THIS PERFORATION MIGHT HAVE OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY CONCERNING THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER