BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR REFURBISHED

    MDR report key: 4329031 · Received December 15, 2014

    Report

    Report Number
    1226420-2014-00123
    Event Type
    Malfunction
    Date Received
    December 15, 2014
    Date of Event
    November 17, 2014
    Report Date
    April 3, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    MUL
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION PROCESS: UNIT RECEIVED IN STANDARD SHIPPING CONTAINER. UNIT RECEIVED IN POOR CONDITION WITH CASE STAINING AND GOUGES. NO POWER CORD NOR USER MANUAL WERE RECEIVED WITH UNIT. TWO PLASMABLADE 3.0 HANDPIECES WERE RECEIVED. INTERNAL VISUAL INSPECTION FOUND NOTHING MOVING OR BROKEN IN UNIT. UNIT DELIVERED RF ENERGY CORRECTLY INTO FIXED RESISTORS. ALL PEAK CUT LEVELS WERE WELL WITHIN SPECIFIED TOLERANCES. UNIT ALSO TESTED WITH SUPPLIED HANDPIECE WITH SATISFACTORY RESULTS FOR CUTS 1-5. ERROR LOG INDICATES THAT THE UCB REAL-TIME CLOCK DIED ON OR AFTER (B)(6) 2014. ROOT CAUSE: THE REPORTED COMPLAINT COULD NOT BE REPLICATED BY THE SERVICE DEPARTMENT; UNIT DELIVERED CORRECT LEVELS OF RF ENERGY IN ALL MODES AND POWER LEVELS (INCLUDING CUT 1-5.) CASE STAINING IS DUE TO THE USE OF AGGRESSIVE CLEANING AGENTS IN THE FIELD. UCB REAL-TIME CLOCK BATTERY DIED DUE TO AGE.

    Description of Event or Problem · 1

    DURING ROUTINE BIOMED TESTING OF THE PULSAR GENERATOR AND PLASMABLADE CUT LEVELS 1-5 WERE HIGHER THAN THE EXPECTED OUTPUT VALUE. ALL OTHER SETTINGS WERE WITHIN SPECIFICATIONS. AN RF 303 BIOTECH ESU WAS USED FOR TESTING WITH A 3.0 DEVICE. THERE WERE NO ERROR CODES. THE UNIT WAS PLUGGED DIRECTLY INTO THE WALL FOR TESTING. NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    DURING ROUTINE BIOMED TESTING OF THE PULSAR GENERATOR AND PLASMABLADE CUT LEVELS 1-5 WERE HIGHER THAN THE EXPECTED OUTPUT VALUE. ALL OTHER SETTINGS WERE WITHIN SPECIFICATIONS. AN RF 303 BIOTECH ESU WAS USED FOR TESTING WITH A 3.0 DEVICE. THERE WERE NO ERROR CODES. THE UNIT WAS PLUGGED DIRECTLY INTO THE WALL FOR TESTING. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820447 GENERATOR PULSAR REFURBISHED GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY, LLC PS100-100RF

    Patients

    Seq Age Sex Outcome Treatment
    1