BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1882367 · Received October 22, 2010

    Report

    Report Number
    1222780-2010-00156
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 23, 2010
    Report Date
    September 23, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE IDENTIFIED LOT NUMBER AND SERIAL NUMBER OF THE DISPOSABLE DEVICE. NO ABNORMALITIES WERE FOUND 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 SYSTEM. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: 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. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) CONTRAINDICATIONS: THE NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM IS CONTRAINDICATED FOR USE IN A PATIENT WITH ANY PATHOLOGIC CONDITION (E.G.), LONG TERM MEDICAL THERAPY) THAT COULD LEAD TO WEAKENING OF THE MYOMETRIUM. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH MANUFACTURER'S REPORT NUMBER 1222780-2010-00155. WHILE POSITIONING A NOVASURE DISPOSABLE DEVICE IN THE UTERINE CAVITY, DURING AN ATTEMPTED ENDOMETRIAL ABLATION, THE PHYSICIAN "FELT THAT IT GAVE TO EASILY". HE PERFORMED A HYSTEROSCOPY AND SAW WHAT HE "SUSPECTED" WAS A PERFORATION. THE PROCEDURE WAS ABANDONED. THE PATIENT "WAS FINE AND WAS DISCHARGED HOME". THE PHYSICIAN REPORTED ON 10/11/2010 THAT THE PATIENT IS DOING FINE. ADDITIONALLY, HE REPORTED BECAUSE THE PATIENT HAS BEEN ON LUPRON THERAPY FOR HEAVY BLEEDING "THE UTERINE LINING HAD BEEN THINNED". A HYSTEROSCOPY WAS PERFORMED PRIOR TO THE ATTEMPTED ABLATION, AS WAS A DILATATION AND SOUNDING WITH A SURESOUND. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 10B15RA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK