BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMAJET SURGICAL SYSTEM

    MDR report key: 4995998 · Received August 6, 2015

    Report

    Report Number
    3004754983-2015-00002
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 6, 2015
    Report Date
    August 5, 2015
    Manufacturer
    PLASMA SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K121977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    THE PLASMAJET SYSTEM WAS USED IN COMBINATION WITH STANDARD LAPAROSCOPIC INSTRUMENTATION FOR THE PROCEDURE. A 28CM LAPAROSCOPIC HANDPIECE WAS SELECTED FOR THE PLASMAJET. THE DEVICE FUNCTIONED AS INTENDED FOR APPROXIMATELY 15 TO 20 MINUTES AT THE BEGINNING OF THE PROCEDURE. AFTER THIS INITIAL USE, A DECREMENT WAS NOTED IN THE PERFORMANCE OF THE DEVICE. THE SURGEONS NOTED THIS AS A DECREASE IN THE POWER OF THE PLASMA. CONTINUED ACTIVATION OF THE HANDPIECE RESULTED IN A SMALL VOLUME OF WATER EXITING FROM THE TIP OF THE PLASMATRON. THE SURGEONS IMMEDIATELY REMOVED AND DISCONTINUED USE OF THE FIRST HANDPIECE. THE SURGEONS APPROXIMATE THE VOLUME OF FLUID AT 20 MILLILITERS OR LESS. PT WAS OBSERVED AS AN INPATIENT TWO (2) EXTRA DAYS AS A CONSERVATIVE MEASURE. POST-OPERATIVE COURSE WAS UNREMARKABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520650 PLASMAJET SURGICAL SYSTEM NEUTRAL PLASMA SURGERY SYSTEM GEI PLASMA SURGICAL INC. V3+/ LS-CP 05/28H RP500003

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization STANDARD LAPAROSCOPIC INSTRUMENTATION