BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR GENERATOR REFURBISHED

    MDR report key: 4814194 · Received June 3, 2015

    Report

    Report Number
    1226420-2015-00093
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    May 4, 2015
    Report Date
    June 25, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS #(B)(4): EVALUATION PROCESS: PERFORMED VISUAL INSPECTION IAW (B)(4): -HEAVY CASE STAINING/GOUGES UNDER SIDE VENTS. -FRONT NYLON SCREW IN BASE OF UNIT BROKEN. PERFORMED BASELINE PERFORMANCE TESTING IAW (B)(4): -NO ISSUES NOTED. -GENERATOR TESTED WITH PLASMABLADE 4.0 AT COAG 8 WITH TISSUE ANALOG TO EVALUATE ARCING COMPLAINT. UNIT WAS FOUND TO GENERATE A PLASMA ARC =1/16¿ FROM THE TISSUE ANALOG. ADDITIONAL GENERATORS IN THE SERVICE AREA WERE ALSO TESTED IN THE SAME WAY WITH IDENTICAL RESULTS. -ERROR LOG INDICATES THAT THE UCB REAL-TIME CLOCK BATTERY DIED ON OR AFTER (B)(6) 2014. ROOT CAUSE: -ALTHOUGH THE GENERATOR DID PRODUCE A PLASMA ARC=1/16¿ IN LENGTH, THIS BEHAVIOR WAS EXHIBITED BY MULTIPLE GENERATORS (INCLUDING GENERATION 2 UNITS) AND IS CONSIDERED NORMAL RF ENERGY BEHAVIOR. -CASE STAINING IS DUE TO THE USE OF AGGRESSIVE CLEANING AGENTS IN THE FIELD. -PHYSICAL DAMAGE IS THE RESULT OF ROUGH HANDLING IN THE FIELD. -UCB REAL-TIME CLOCK BATTERY DIED DUE TO AGE. SYSTEM APPROACH: THROUGH THE EVALUATION OF THE RETURNED GENERATOR AND DEVICE IT WAS DETERMINED THAT BOTH COMPONENTS FUNCTIONED AS INTENDED. THE REPORTED ISSUE WAS CONFIRMED TO EXHIBIT ARCING, HOWEVER THIS IS THE NORMAL FUNCTIONALITY OF THE SYSTEM, AND NOT A MALFUNCTION. THE LIKELY CAUSE OF THE REPORTED ISSUE IS THAT THE ENVIRONMENT OF THE OR, OR THE MANNER IN WHICH THE SYSTEM WAS UTILIZED CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4), EVAL METHOD/RESULTS/CONCLUSIONS:: PRODUCT CURRENTLY NOT SCHEDULED FOR RETURN TO MANUFACTURER FOR INSPECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING A MASTECTOMY CASE IT WAS REPORTED BY THE SURGEON THAT THE PLASMABLADE WAS ARCING WHILE UTILIZED IN COAG MODE. THE FACILITY IS UTILIZING THE PB ON CUT 6 COAG 8. WHEN THE DEVICE WAS ACTIVATED IT WAS BELIEVED TO HAVE BEEN BEING ACTIVATED ON TISSUE OR DIRECTLY ABOVE IN ANTICIPATION OF TOUCHING TISSUE HOWEVER, THE SURGEON COULD NOT OFFICIALLY CLARIFY. SURGEON COMPLETED THE CASE WITH THE GENERATOR AND DEVICE WITH NO PATIENT IMPACT.

    Description of Event or Problem · 1

    DURING A MASTECTOMY CASE IT WAS REPORTED BY THE SURGEON THAT THE PLASMA BLADE WAS ARCING WHILE UTILIZED IN COAG MODE. THE FACILITY IS UTILIZING THE PB ON CUT 6 COAG 8. WHEN THE DEVICE WAS ACTIVATED IT WAS BELIEVED TO HAVE BEEN BEING ACTIVATED ON TISSUE OR DIRECTLY ABOVE IN ANTICIPATION OF TOUCHING TISSUE HOWEVER, THE SURGEON COULD NOT OFFICIALLY CLARIFY. SURGEON COMPLETED THE CASE WITH THE GENERATOR AND DEVICE WITH NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359095 PULSAR GENERATOR REFURBISHED ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-100RF

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR