BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMAJET NEUTRAL PLASMA SURGERY CONSOLE

    MDR report key: 3573380 · Received November 1, 2013

    Report

    Report Number
    3004754983-2013-00002
    Event Type
    Malfunction
    Date Received
    November 1, 2013
    Date of Event
    November 16, 2004
    Report Date
    November 1, 2013
    Manufacturer
    PLASMA SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K030819
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT EVALUATED AGAINST KNOWN OPERATING SPECIFICATIONS. THE FOLLOWING CORRECTIVE ACTIONS WERE IMPLEMENTED TO ADDRESS THE POTENTIAL RISK INDICATED: AUDIBLE TONE ADDED TO ALERT USERS AS TO WHEN THE PLASMA HAS BEEN IGNITED; HANDPIECE HOLSTER TO ACCOMPANY EACH HANDPIECE TO ALLOW FOR SAFE STORAGE WHEN NOT IN USE.

    Description of Event or Problem · 1

    THE EQUIPMENT WAS BEING PREPARED FOR USE. THE HANDPIECE HAD BEEN CONNECTED AND CHECKED AND LAID ONTO THE STERILE AREA OF OPERATION. THE CIRCULATION NURSE, WHILE ATTEMPTING TO MAKE THE FOOTSWITCH SAFE, PUSHED IT UNDER THE SERVICE TROLLEY. THE PEDAL CAUGHT ON THE UNDERSIDE OF THE TROLLEY AND THE SWITCH WAS ACTIVATED, CAUSING THE PLASMA TO LIGHT. THIS WAS ONLY NOTICED WHEN THE DOCTOR SMELLED BURNING FROM THE SLEEVE OF THE HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565086 PLASMAJET NEUTRAL PLASMA SURGERY CONSOLE NONE GEI PLASMA SURGICAL INC. PS-2100-01

    Patients

    Seq Age Sex Outcome Treatment
    1