BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 2112356 · Received May 25, 2011

    Report

    Report Number
    1222780-2011-00091
    Event Type
    Injury
    Date Received
    May 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 OF THE DISPOSABLE NOVASURE DEVICE IS NOT KNOWN. SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. NEITHER THE DEVICE NOR RADIO FREQUENCY CONTROLLER IS BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THIS NOVASURE SYSTEM CANNOT BE COMPLETED. LOT AND SERIAL NUMBERS NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE MFR DATE OF THE DISPOSABLE DEVICE AND RADIO FREQUENCY CONTROLLER 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 (DHR) AND STERILE LOT REVIEW COULD NOT BE CONDUCTED FOR THE DISPOSABLE DEVICE OR THE RADIO FREQUENCY CONTROLLER (RFC) AS LOT AND SERIAL NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. IF ADDITIONAL RELEVANT INFO IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) OTHER ADVERSE EVENTS: THE FOLLOWING ADVERSE EVENT COULD OCCUR OR HAVE BEEN REPORTED IN ASSOCIATION WITH THE USE OF THE NOVASURE SYSTEM: INFECTION OR SEPSIS. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED THE PHYSICIAN EXPERIENCED "MULTIPLE CASES OF ENDOMETRITIS FOLLOWING NOVASURE OVER ABOUT A 6-WEEKS PERIOD". FOLLOW-UP ON (B)(6) 2011, INDICATED THAT THERE WERE "POSSIBLY TWO CASES" OF ENDOMETRITIS. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFO SURROUNDING THIS EVENT.

    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 Other RADIO FREQUENCY CONTROLLER - SERIAL NUMBER UNKNOWN