BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR 2 GENERATOR

    MDR report key: 5500007 · Received March 15, 2016

    Report

    Report Number
    1226420-2016-00028
    Event Type
    Malfunction
    Date Received
    March 15, 2016
    Date of Event
    January 26, 2016
    Report Date
    March 1, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    GEI
    PMA / PMN Number
    K102029
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: *PERFORMED VISUAL INSPECTION ON UNIT PER TCL-514-900008. -SCRAPES LOCATED ON BOTTOM CHASSIS. -SMALL SCRATCH ON FRONT PANEL OVERLAY, OUTSIDE OF AND TO THE RIGHT OF THE VIEWING AREA. -PHYSICAL DAMAGE IDENTIFIED HAD NO IMPACT TO FUNCTIONALITY OF UNIT. *PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-9000008. -RF OUTPUT MEASUREMENTS WERE FOUND TO BE OVER THE UPPER LIMITS. FIVE OF THE OUTPUT TESTING DURING EVALUATION GENERATED E7 ERRORS DUE TO EXCESSIVE VOLTAGE. -DC PCBA WAS FOUND TO BE AT FAULT FOR E7 ERRORS AND ALL OVER-LIMIT RF OUTPUTS. RESISTORS R151 WAS FOUND TO BE IN A FAMILY (OPEN) CONDITION PREVENTING PROPER VOLTAGE CONTROL FEEDBACK OF 600VDC CIRCUITRY. -THE CONDUCTIVE TRACE BETWEEN D14 AND RT2 ON THE DC PCBA WAS DESTROYED DURING TROUBLESHOOTING WHEN MULTIMETER LEAD SLIPPED AND SHORTED Q13, DC PCBA WILL NEED TO BE SCRAPPED. ROOT CAUSE: THE PULSAR II PRODUCED E7 ERRORS (¿GENERATOR VOLTAGE ERROR¿) INSTEAD OF DELIVERING RF ENERGY BECAUSE OF FAILED RESISTOR R151 ON THE DC POWER PCBA. ITS FAILURE CAUSED THE EXCESSIVE LEVELS OF OUTPUT ENERGY. THE SCRAPED AND SCRATCHES ON THE UNIT ARE CONSISTENT AND ROUGH HANDLING IN THE FIELD. ADDITIONAL INFORMATION RECEIVED 1 MAR 2016 (BOISVK1): DURING INCOMING TEST, IT WAS FOUND THAT THE SUBJECT PULSAR II WOULD EITHER GENERATE E7 ERRORS (OVERVOLTAGE) OR DELIVER A LEVEL OF POWER MUCH HIGHER THAN DESIRED. HERE¿S THE DATA FROM THE INCOMING TEST: EXPECTED POWER VERSUS ACTUAL POWER FOR PULSAR II (B)(4) 10W MEDIUM CUT - 229MA => 21.0W -- 110% ABOVE RATED POWER 30W MEDIUM CUT - 394MA => 62.0W -- 107% ABOVE RATED POWER 60W MEDIUM CUT - E7 ERROR INSTEAD OF ENERGY DELIVERY 10W HIGH CUT 1 - 221MA => 19.5W -- 95% ABOVE RATED POWER 30W HIGH CUT 1 - 375MA => 56.3W -- 88% ABOVE RATED POWER 50W HIGH CUT 1 - 472MA => 89.1W -- 78% ABOVE RATED POWER 10W HIGH CUT 2 - 222MA => 19.7W -- 97% ABOVE RATED POWER 30W HIGH CUT 2 - 377MA => 56.9W -- 90% ABOVE RATED POWER 60W HIGH CUT 2 - 511MA => 104W -- 73% ABOVE RATED POWER 10W LOW COAG 1 - 223MA => 19.9W -- 99% ABOVE RATED POWER 30W LOW COAG 1 - 378MA => 57.2W -- 91% ABOVE RATED POWER 60W LOW COAG 1 - E7 ERROR INSTEAD OF ENERGY DELIVERY 10W HIGH COAG - 193MA => 18.6W -- 86% ABOVE RATED POWER 30W HIGH COAG - 330MA => 54.4W -- 81% ABOVE RATED POWER 60W HIGH COAG - E7 ERROR INSTEAD OF ENERGY DELIVERY DEBUG OF THE UNIT FOUND THAT THE ¿BULK VOLTAGE¿ GENERATED BY THE DC POWER BOARD MEASURED ABOUT 750V INSTEAD OF THE DESIRED 600V. ADDITIONAL DEBUG REVEALED THAT RESISTOR R151 ON THE DC POWER BOARD HAD FAILED IN THE OPEN CONDITION: THIS OPENED UP THE FEEDBACK LOOP SUCH THAT THE BOOST CONVERTER WASN¿T STOPPING WHEN THE VOLTAGE REACHED 600V: IT KEPT RUNNING AT MAXIMUM DUTY CYCLE¿WHICH RESULTED IN THE 750V BULK VOLTAGE.THE VOLTAGE APPLIED TO THE RF CIRCUITRY IS BASICALLY A SCALED DOWN VERSION OF THE BULK VOLTAGE. WITH THE BULK VOLTAGE TOO HIGH, THE OUTPUT VOLTAGE (AND THE RESULTING OUTPUT POWER) WAS TOO HIGH. (B)(4). NO PATIENT INVOLVED AS REPORTABLE MALFUNCTION IDENTIFIED DURING ANALYSIS AND NOT A CUSTOMER LOCATION, THEREFORE PATIENT INFORMATION NOT OBTAINED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT UPON FIRST ACTIVATION OF THE PLASMABLADE, AN E-7 ERROR WAS DISPLAYED. THE GENERATOR WAS RESTARTED AND AN ALTERNATE PLASMABLADE WAS UTILIZED WITH NO RESOLUTION, AS THE E-7 ERROR RECURRED. A DIFFERENT GENERATOR WAS USED WITH ONE OF THE SAME HANDPIECES TO COMPLETE THE CASE. DURING ANALYSIS OF THE GENERATOR IT WAS DETERMINED THAT IN "LOW POWER" MODES THE GENERATOR DELIVERED A HIGHER THEN EXPECTED (SPECIFIED) LEVEL OF RF ENERGY AND NO E7 AS EXPECTED OCCURRED. IN "HIGH POWER" MODES THE GENERATOR ISSUED AN E7 ERROR CODE AS EXPECTED AND RF ENERGY DELIVERY WAS SUSPENDED. A COMPONENT ON THE DC POWER BOARD WAS FOUND TO HAVE FAILED CAUSING THE EXCESS RF ENERGY DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156336 PULSAR 2 GENERATOR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1