BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMAJET SYSTEM

    MDR report key: 814117 · Received January 30, 2007

    Report

    Report Number
    3004748112-2007-00001
    Event Type
    Other
    Date Received
    January 30, 2007
    Date of Event
    December 20, 2006
    Report Date
    January 18, 2007
    Manufacturer
    PLASMA SURGICAL LTD
    Product Code
    GEI
    PMA / PMN Number
    k030819
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THERE WAS NO PT INVOLVEMENT OR INJURY IN THIS INCIDENT. AS THE REPORTED FAULT WAS NOT REPRODUCIBLE AND THERE WAS NO EVIDENCE OF COMPONENT FAILURE, BASED ON TESTING CONDUCTED BY PLASMA SURGICAL LTD IN JANUARY 2007, THE COMPANY CONCLUDES THAT THIS WAS LIKELY TO BE A USER ERROR (INADVERTENT DEPRESSION OF THE ACTIVATION SWITCH) CAUSING THE ARGON PLASMA BEAM TO ACTIVATE WHEN THE HANDPIECE WAS CLOSE TO COMBUSTIBLE MATERIAL. WARNING SYSTEMS WERE ALL FUNCTIONAL AT THE TIME OF TEST AND REVIEW OF LABELING CONFIRMS THIS RISK IS ALREADY ADDRESSED.

    Description of Event or Problem · 1

    THE PLASMAJET SYSTEM WAS PREPARED FOR USE IN A CASE AND THE HANDPIECE PLACED ON AN INSTRUMENT TRAY. AFTER ABOUT 10 TO 15 MINUTES, THE HANDPIECE ARGON BEAM TRIGGERED AND BURNED THE DRAPE AND MELTED THE HANDPIECE TUBING FACING THE PLASMA BEAM. WATER STARTED LEAKING FROM THE HANDPIECE TUBING. THE HANDPIECE HAD NOT BEEN USED AT THIS POINT IN THE CASE. THE HANDPIECE WAS REPLACED WITH ANOTHER DISPOSABLE HANDPIECE AND USING THE ORIGINAL PLASMAJET CONSOLE, WORKED WITHOUT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMAJET SYSTEM NEUTRAL PLASMA COAGULATOR GEI PLASMA SURGICAL LTD PS10-2100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention PART NUMBER PC20-2055, LOT NUMBER 011.3.| PLASMAJET 5 MM OPEN SURGERY HANDPIECE (DISPOSABLE)