BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR 2 GENERATOR

    MDR report key: 4534046 · Received February 23, 2015

    Report

    Report Number
    1226420-2015-00031
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Date of Event
    January 26, 2015
    Report Date
    May 29, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # 700842528 EVALUATION CODE (METHOD): GENERATOR RETURNED AND PENDING ANALYSIS RESULTS EVALUATION CODE (RESULT): GENERATOR RETURNED AND PENDING ANALYSIS RESULTS EVALUATION CODE (CONCLUSION): GENERATOR RETURNED AND PENDING ANALYSIS RESULTS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION PROCESS: *PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -UNIT IS IN GOOD CONDITION. *PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. -NO ISSUES FOUND. UNIT DELIVERED CORRECT LEVELS OF RF ENERGY IN ALL MODES. UNIT WAS CONFIGURED AS DESCRIBED IN MEDTRONIC DOCUMENT #70-10-1231 (¿PULSAR GENERATOR PREVENTATIVE MAINTENANCE GUIDE¿) FOR MEASURING PEAK CUT 5 ENERGY. THE GENERATOR WAS FOUND TO DELIVER 23.9W OF ENERGY, WITHIN THE TOLERANCE BAND OF +/- 20% FROM THE TARGET POWER OF 20W. ROOT CAUSE: SERVICE DEPARTMENT COULD NOT DUPLICATE ISSUE. UNIT DELIVERED CORRECT LEVELS OF RF ENERGY IN ALL MODES, INCLUDING CUT 5 WITH A 3.0S HANDPIECE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER WAS PERFORMING INCOMING INSPECTION OF PULSAR GENERATOR AND PLASMABLADE DEVICE AND NOTED THE GENERATOR HAD HIGH OUTPUT ON CUT SETTING 5. THE GENERATOR SHOULD BE GIVING 20 WATTS WITH AND IMPEDANCE OF 100 OHMS, +/- 20%, HOWEVER THE GENERATOR WAS GIVING 86.3 WATTS AT 100 OHMS. CUSTOMER WAS TESTING WITH 3.0S AND FLUKE RF303 ESU ANALYZER. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    CUSTOMER WAS PERFORMING INCOMING INSPECTION OF PULSAR GENERATOR AND PLASMABLADE DEVICE AND NOTED THE GENERATOR HAD HIGH OUTPUT ON CUT SETTING 5. THE GENERATOR SHOULD BE GIVING 20 WATTS WITH AND IMPEDANCE OF 100 OHMS, +/- 20%, HOWEVER THE GENERATOR WAS GIVING 86.3 WATTS AT 100 OHMS. CUSTOMER WAS TESTING WITH 3.0S AND FLUKE RF303 ESU ANALYZER. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125413 PULSAR 2 GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1