BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1289925 · Received January 16, 2009

    Report

    Report Number
    1222780-2009-00006
    Event Type
    Injury
    Date Received
    January 16, 2009
    Date of Event
    December 18, 2008
    Report Date
    December 18, 2008
    Manufacturer
    CYTYC SURGICAL PRODUCTS
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR THE DISPOSABLE DEVICES AND RADIO FREQUENCY CONTROLLER. THESE DEVICES WERE RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. EXPIRATION DATE OF RFC - NA. DEVICE MFR DATE OF RFC - 05/2006. ACCORDING TO THE INSTRUCTIONS FOR USE (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 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 JUDGMENT MUST ALWAYS BE USED.

    Description of Event or Problem · 1

    USER FACILITY REPORTED MULTIPLE UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS DURING A NOVASURE PROCEDURE. THE PROCEDURE WAS ABANDONED AND HYSTEROSCOPY DONE, WHICH CONFIRMED A UTERINE PERFORATION. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB CYTYC SURGICAL PRODUCTS NS2000 08F10HA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER