BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 1841127 · Received September 17, 2010

    Report

    Report Number
    1222780-2010-00138
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    June 1, 2010
    Report Date
    August 20, 2010
    Manufacturer
    HOLOGIC
    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

    LOT AND SERIAL NUMBER NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE 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. IF ADDITIONAL RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. 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 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. (B)(4).

    Description of Event or Problem · 1

    USER FACILITY REPORTED DIFFICULTY SEATING THE DISPOSABLE DEVICE DUE TO A "SMALL UTERINE CAVITY" DURING AN ATTEMPTED NOVASURE ENDOMETRIAL ABLATION. THE PROCEDURE WAS ABANDONED AND A 1 CM UTERINE PERFORATION WAS CONFIRMED. THE PT WAS ADMITTED TO THE HOSPITAL AND "DEVELOPED A TEMPERATURE AND WAS IN PAIN." A HYSTERECTOMY WAS PERFORMED (NOT TREATMENT FOR THE PERFORATION) AND THE PT "RECOVERED WELL AND WAS DISCHARGED AS NORMAL." UPON FOLLOW-UP, THE PT'S CONDITION WAS REPORTED AS "GOOD." A HYSTEROSCOPY AS WELL AS A DILATATION AND CURETTAGE (D&C) 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 UNK Hospitalization RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNK