BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II

    MDR report key: 5540806 · Received April 1, 2016

    Report

    Report Number
    1226420-2016-00029
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    March 4, 2016
    Report Date
    May 12, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY (SALIENT)
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. UNIT HAS BARE METAL ON BOTH BOTTOM SIDES OF ENCLOSURE (ENCLOSURE REQUIRES REPLACEMENT). PHYSICAL DAMAGE IDENTIFIED HAD NO IMPACT TO FUNCTIONALITY OF THE UNIT INTERNAL INSPECTION ¿ COMPONENT U21 ON THE ROHS DC POWER PCBA HAS EXTENSIVE THERMAL DAMAGE IN THE MIDDLE OF THE INTEGRATED CIRCUIT PACKAGE. PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. DURING EVALUATION THE UNIT DID NOT DELIVER RF ENERGY OUTPUT POWER IN EITHER CUT OR COAG. DEBUGGED UNIT DOWN TO DEFECTIVE ROHS DC POWER PCBA. UPGRADED MONOPOLAR ROOT CAUSE: REPORTED CONDITION COULD NOT BE CONFIRMED: THE UNIT DID NOT DELIVER ANY ENERGY OUTPUT UPON ARRIVAL DUE TO FAILURE OF MULTIPLE COMPONENTS ON THE DC POWER PCBA. AS RECEIVED, THE DC POWER PCBA COULD NOT GENERATE 600V, SO THE UNIT COULD NOT DELIVER ANY OUTPUT RF ENERGY. REPLACEMENT OF THE DC POWER PCBA RESTORED FUNCTION TO THE UNIT. ONCE THE DC POWER PCBA WAS REPLACED, THE UNIT CORRECTLY DELIVERED RATED LEVELS OF ENERGY WITH NO ISSUES. EFFORTS TO REPLICATE THE ¿ARCING¿ COMPLAINT ON THE BENCH WERE UNSUCCESSFUL: THE UNIT WAS FOUND TO OPERATE AS DESIGNED. DEBUG OF THE DC POWER PCBA REVEALED THAT COMPONENT U21 FAILED CATASTROPHICALLY (THERE WAS A THERMAL ¿CRATER¿ IN THE IC PACKAGE) FOR REASONS UNKNOWN. THE FAILURE OF THIS MOSFET DRIVER CHIP LED TO THE FAILURE (SHORTED CONDITION) OF MOSFETS Q8 AND Q9, WHICH PREVENTED THE UNIT FROM BEING ABLE TO DELIVER AND RF ENERGY TO A PATIENT.

    Additional Manufacturer Narrative · 1

    (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

    UPON ACTIVATION OF THE DEVICE THE SURGEON REPORTED ENERGY ARCHED FROM THE DEVICE TO ANOTHER INSTRUMENT HE WAS USING. THERE WAS NO REPORTED PATIENT OR USER IMPACT.

    Description of Event or Problem · 1

    UPON ACTIVATION OF THE DEVICE, THE SURGEON REPORTED ENERGY ARCHED FROM THE DEVICE TO ANOTHER INSTRUMENT HE WAS USING. THERE WAS NO REPORTED PATIENT OR USER IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197083 GENERATOR PULSAR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY (SALIENT) PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR