BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR II GENERATOR

    MDR report key: 4272014 · Received November 24, 2014

    Report

    Report Number
    1226420-2014-00112
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    September 30, 2014
    Report Date
    February 16, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT # (B)(4). EVALUATION, (METHOD), (RESULT),(CONCLUSION): PENDING RETURN OF PRODUCT FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) BRIEF DESCRIPTION OF COMPLAINT: GENERATOR FAILED BIOMED TESTING DUE TO HIGH OUTPUT VALUES. EVALUATION PROCESS: *PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -UNIT HAS SCRATCHES DOWN TO THE EXPOSED METAL. -MONOPOLAR RECEPTACLE IS LOOSE: ONE OF THE TWO INTERNAL PLASTIC MOUNTING TABS IS BROKEN OFF. IT WAS FOUND WEDGED IN A CORNER OF THE ENCLOSURE. *PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. -NO ISSUES FOUND. UNIT DELIVERED RF ENERGY PROPERLY IN ALL MODES. THE REPORT DOESN¿T STATE WHICH HANDPIECE WAS USED FOR THE EVALUATION, BUT CUT 9 AND CUT 10 ARE GENERALLY HIGH CUT 1 AND HIGH CUT 2 MODES, 25W OR GREATER. THE TESTING PERFORMED IN THE SERVICE DEPARTMENT MEASURE THE FOLLOWING VALUES IN THOSE MODES: 30W HIGH CUT 1: 30.3W 50W HIGH CUT 1: 50.4W 30W HIGH CUT 2: 29.6W 60W HIGH CUT 2: 59.9W IT WAS FOUND THAT POWER MEASUREMENTS IN ALL MODES WERE WELL WITHIN THE REQUIRED POWER SPREAD OF +/-20%, WITH THE POWER SPREAD FOR HIGH CUT1 AND HIGH CUT 2 MEASUREMENTS, IN PARTICULAR, MEASURING WITHIN 30% OF THEIR TARGET VALUES. ROOT CAUSE: COULD NOT REPLICATE HIGH OUTPUT ON CUT 9 AND CUT 10: UNIT GENERATED RATED POWER WITHIN PERMISSIBLE POWER SPREAD IN ALL MODES. (B)(4).

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTENANCE CHECK OF THE PULSAR II GENERATOR SETTING CUT 9 GENERATED A HIGH OUTPUT READING. ALL OTHER SETTINGS WERE WITHIN NORMAL LIMITS. THE UNIT WAS PLUGGED DIRECTLY INTO THE WALL AND A FLUKE SCOPEMETER WAS USED FOR TESTING. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING A ROUTINE PREVENTATIVE MAINTAINENCE CHECK OF THE PULSAR II GENERATOR SETTING CUT 9 GENERATED A HIGH OUTPUT READING. ALL OTHER SETTINGS WERE WITHIN NORMAL LIMITS. THE UNIT WAS PLUGGED DIRECTLY INTO THE WALL AND A FLUKE SCOPEMETER WAS USED FOR TESTING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760134 PULSAR II GENERATOR GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1