BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVASURE IMPEDANCE CONTROLLED EA SYSTEM

    MDR report key: 3021094 · Received March 15, 2013

    Report

    Report Number
    1222780-2013-00048
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 15, 2013
    Manufacturer
    HOLOGIC
    Product Code
    MNB
    PMA / PMN Number
    P010013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT. CONCOMITANT MEDICAL PRODUCTS: SERIAL NUMBER OF THE RADIO FREQUENCY CONTROLLER NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A NOVASURE ENDOMETRIAL ABLATION THE PHYSICIAN PERFORMED A LAPAROSCOPY FOR A TUBAL LIGATION. AT THAT TIME THE PHYSICIAN NOTED A "SMALL PERFORATION AT THE TOP OF THE FUNDUS AND ALSO SOME BLANCHING". THE PHYSICIAN CAUTERIZED THE PERFORATION AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013 IT WAS REPORTED THE PATIENT "IS DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110467 NOVASURE IMPEDANCE CONTROLLED EA SYSTEM MNB HOLOGIC NS2000 11J08R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention RADIO FREQUENCY CONTROLLER: SERIAL NUMBER UNKNOWN