BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II

    MDR report key: 4325925 · Received December 12, 2014

    Report

    Report Number
    1226420-2014-00119
    Event Type
    Malfunction
    Date Received
    December 12, 2014
    Date of Event
    November 14, 2014
    Report Date
    April 3, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    MUL
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION PROCESS: PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -NO ISSUES FOUND. PERFORMED BASELINE FUNCTIONAL TESTING PERTCL-514-900008. -UNIT DELIVERED CORRECT LEVELS OF RF ENERGY IN ALL MODES. UNIT WAS TESTED OVER AN EXTENDED PERIOD OD TIME; KEYED FOR 12 MINUTES AT 6W LOW COAG 1 (15S ON, 15S OFF) AND THEN FOR 12MINUTES AT 50W HIGH COAG (15S ON, 15S OFF) WHILE BEING OBSERVED. THE LCD WAS ONCE OBSERVED TO LOCK UP WITH THE LCD AND SPEAKER INDICATING THAT ENERGY WAS BEING DELIVERED DESPITE THE HANDPIECE BUTTON BEING RELEASED AND NO ENERGY BEING DELIVERED TO THE HANDPIECE. LATER, THE LCD WAS ONCE OBSERVED SUDDENLY CHANGING THE SCREEN AND TURNING OFF THE SPEAKER ALTHOUGH THE HANDPIECE BUTTON WAS STILL BEING HELD DOWN AND ENERGY WAS STILL BEING DELIVERED TO THE HANDPIECE. FOR REASONS UNKNOWN, THIS PARTICULAR LCD ASSEMBLY IS DEFECTIVE IN THAT IT IS SUSCEPTIBLE TO THE ELECTROMAGNETIC NOISE GENERATED BY THE DELIVERY OF COAG ENERGY. IT MUST BE REPLACED. NO ISSUES WERE DETECTED WITH THE DELIVERY OF CUT ENERGY, WHICH DOES NOT GENERATOR AS MUCH ELECTROMAGNETIC NOISE AS THE DELIVERY OF COAG ENERGY DOES. ROOT CAUSE: THE REPORTED PROBLEM WAS REPLICATED; THE LCD ASSEMBLY IN THIS UNIT, FOR REASONS UNKNOWN, IS SUSCEPTIBLE TO THE ELECTROMAGNETIC NOISE GENERATED BY THE DELIVERY OF COAG ENERGY AND DOES NOT ALWAYS ACCURATELY, CORRECTLY REFLECT THE STATUS OF THE HEADPIECE COAG BUTTON. NOTE, HOWEVER, THAT THE PRESENCE OR ABSENCE OF COAG ENERGY TO THE HANDPIECE ALWAYS MATCHED THE STATUS OF THE COAG BUTTON.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD, RESULTS, CONCLUSION: PRODUCT RECEIVED BY MANUFACTURER AND PENDING INSPECTION. PRODUCT EVENT: (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

    A FEW MINUTES INTO THE CASE, AFTER THE CUSTOMER STOPPED DEPRESSING THE COAG BUTTON, THE GENERATOR STILL SHOWED AS ACTIVE AND STILL GAVE THE COAG TONE, HOWEVER THE HAND PIECE WASNACTIVE (THERE WAS NO RF ENERGY GOING TO THE HAND PIECE). THE GENERATOR WAS RESTARTED AND THE ISSUE WAS RESOLVED. APPROXIMATELY 10 MINUTES LATER, WHILE BEING USED ON COAG, THE GENERATOR STOPPED SHOWING AS ACTIVE, THERE WAS NO ACTIVATION TONE AND THE SCREEN DID NOT INDICATED COAG AS ACTIVE. THIS OCCURRED ALTHOUGH THE CUSTOMER WAS CONTINUING TO DEPRESS THE COAG BUTTON ON THE HAND PIECE AND THE HAND PIECE ITSELF WAS STILL COAGULATING AND STILL HAD RF ENERGY GOING TO IT. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER STOPPED DEPRESSING COAG ON THE HAND PIECE. APPROXIMATELY 15 MINUTES LATER, AFTER A SUBSEQUENT ACTIVATION ON COAG, WHEN THE CUSTOMER STOPPED DEPRESSING THE COAG BUTTON, THE GENERATOR STILL SHOWED AS ACTIVE AND STILL GAVE THE COAG TONE, HOWEVER THE HAND PIECE WASN'T ACTIVE AND THERE WAS NO RF ENERGY GOING TO THE HAND PIECE. A DIFFERENT GENERATOR WAS BROUGHT IN AND USED WITH THE SAME HAND PIECE TO SUCCESSFULLY COMPLETE THE CASE. CUT WAS NOT AFFECTED.

    Description of Event or Problem · 1

    A FEW MINUTES INTO THE CASE, AFTER THE CUSTOMER STOPPED DEPRESSING THE COAG BUTTON, THE GENERATOR STILL SHOWED AS ACTIVE AND STILL GAVE THE COAG TONE, HOWEVER, THE HAND PIECE WASN¿T ACTIVE (THERE WAS NO RF ENERGY GOING TO THE HAND PIECE). THE GENERATOR WAS RESTARTED AND THE ISSUE WAS RESOLVED. APPROXIMATELY 10 MINUTES LATER, WHILE BEING USED ON COAG, THE GENERATOR STOPPED SHOWING AS ACTIVE, THERE WAS NO ACTIVATION TONE AND THE SCREEN DID NOT INDICATED COAG AS ACTIVE. THIS OCCURRED ALTHOUGH THE CUSTOMER WAS CONTINUING TO DEPRESS THE COAG BUTTON ON THE HAND PIECE AND THE HAND PIECE ITSELF WAS STILL COAGULATING AND STILL HAD RF ENERGY GOING TO IT. THE ISSUE WAS RESOLVED WHEN THE CUSTOMER STOPPED DEPRESSING COAG ON THE HAND PIECE. APPROXIMATELY 15 MINUTES LATER, AFTER A SUBSEQUENT ACTIVATION ON COAG, WHEN THE CUSTOMER STOPPED DEPRESSING THE COAG BUTTON, THE GENERATOR STILL SHOWED AS ACTIVE AND STILL GAVE THE COAG TONE, HOWEVER THE HAND PIECE WASN¿T ACTIVE AND THERE WAS NO RF ENERGY GOING TO THE HAND PIECE. A DIFFERENT GENERATOR WAS BROUGHT IN AND USED WITH THE SAME HAND PIECE TO SUCCESSFULLY COMPLETE THE CASE. CUT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807086 GENERATOR PULSAR II GENERATOR,ELECTROSURGICAL,COAGULATION,CANCER MUL MEDTRONIC ADVANCED ENERGY LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR