BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1748016 · Received July 2, 2010

    Report

    Report Number
    1222780-2010-00103
    Event Type
    Injury
    Date Received
    July 2, 2010
    Date of Event
    June 10, 2010
    Report Date
    June 11, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG # OF THE RADIO FREQUENCY CONTROLLER 816001-2. (B)(4). RETURN OF RADIO FREQUENCY CONTROLLER TO MANUFACTURER ON: 06/18/2010. DEVICE MANUFACTURER DATE OF THE RADIO FREQUENCY CONTROLLER: 02/2005. DEVICE HISTORY RECORD (DHR) REVIEWS WERE CONDUCTED FOR THE RETURNED DISPOSABLE DEVICES AND RADIO FREQUENCY CONTROLLER. NO ABNORMALITIES WERE NOTED RELATED TO THE REPORTED INFORMATION AND THE DEVICES 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. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS WITH 2 DISPOSABLE DEVICES DURING AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION. THE PROCEDURE WAS ABANDONED AND A "SMALL PERFORATION" WAS CONFIRMED ON POST HYSTEROSCOPY. THE PHYSICIAN REPORTED NO TREATMENT WAS NEEDED FOR THE PERFORATION, BUT THE PT WAS ADMITTED OVER NIGHT FOR OBSERVATION. SHE WAS FINE AND DISCHARGED HOME THE NEXT DAY. THE PHYSICIAN REPORTED ON (B)(6) 2010 THAT THE PT HAS BEEN SEEN ON F/U, SHE IS DOING FINE, AND THEY PLAN TO REPEAT THE NOVASURE PROCEDURE IN A COUPLE OF WEEKS. A HYSTEROSCOPY AND SOUNDING WITH A METAL SOUND (NOT A HOLOGIC DEVICE) WERE PERFORMED PRIOR TO THE ATTEMPTED ABLATION. 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 09M11R (2 DEVICES)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization RADIO FREQUENCY CONTROLLER - (B)(4)