BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2893388 · Received December 28, 2012

    Report

    Report Number
    1222780-2012-00287
    Event Type
    Injury
    Date Received
    December 28, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 28, 2012
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE MYOSURE CONTROL UNIT, HYSTEROSCOPE AND AQUILEX FLUID CONTROL SYSTEM NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE MANUFACTURE DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE LOT NUMBER WAS 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 OF THE UTERINE CAVITY, AND SOUNDS AN ALARM WARNING OF A POSSIBLE PERFORATION PRIOR TO TREATMENT. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MFR¿S REPORT NUMBER: 1222780-2012-00287. DURING A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL THERE WAS A FLUID DEFICIT IMMEDIATELY AFTER THE PHYSICIAN STARTED TO CUT THE FIBROID. AT ¿3 MINUTES¿ THE PT¿S FLUID DEFICIT WAS 2700 CC. SALINE WAS USED FOR THE DISTENTION MEDIUM. THE PHYSICIAN SUSPECTED A PERFORATION AND ABORTED THE MYOSURE PROCEDURE. A HYSTEROSCOPY WAS PERFORMED, BUT NO PERFORATION VISUALIZED. AT THIS POINT, THE PHYSICIAN THEN PERFORMED A NOVASURE ENDOMETRIAL ABLATION AND RECEIVED THREE UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TESTS. THE PHYSICIAN ABORTED THE NOVASURE AND PERFORMED A HYSTERECTOMY AT THE PT¿S REQUEST. THE PATIENT DID NOT EXHIBIT SYMPTOMS OF FLUID DEFICIT AND THERE WAS NO INTERVENTION TO THE PATIENT DUE TO THE FLUID DEFICIT. ON (B)(6) 2012, IT WAS REPORTED THE PT WAS ¿DOING FINE¿.

    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| O| R RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNK| MYOSURE HYSTEROSCOPE: SERIAL NUMBER UNK| AQUILEX FLUID MANAGEMENT SYSTEM: SERIAL NUMBER UNK