BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1881097 · Received October 20, 2010

    Report

    Report Number
    1222780-2010-00154
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXP DATE IS NOT KNOWN. THE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CAN NOT BE COMPLETED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MFR DATE IS NOT KNOWN. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. 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. 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

    IT WAS REPORTED THAT SEVERAL UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS OCCURRED DURING AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION PROCEDURE. THE PROCEDURE WAS ABANDONED AND A 1-2MM PERFORATION ON THE BACK SIDE OF THE UTERUS WAS CONFIRMED DURING AN SCHEDULED LAPAROSCOPIC TUBAL LIGATION. THE PERFORATION WAS TREATED WITH A BI-POLAR CAUTERY. THE PHYSICIAN REPORTED THE PT WAS "FINE" AS OF 09/23/10. A HYSTEROSCOPY, DILATATION AND CURETTAGE (D&C), 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other RADIO FREQUENCY CONTROLLER - SERIAL # UNK