BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR II

    MDR report key: 4501370 · Received February 10, 2015

    Report

    Report Number
    1226420-2015-00028
    Event Type
    Malfunction
    Date Received
    February 10, 2015
    Date of Event
    November 26, 2014
    Report Date
    January 14, 2015
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K102029
    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 (B)(4). -UNIT HAS LIGHT SCRATCHES. *PERFORMED BASELINE FUNCTIONAL TESTING PER TCL-514-900008. -OUTPUT POWER IN MEDIUM CUT MODE (SETTINGS 6, 7, AND 8 ON A PLASMABLADE 4.0) WAS OBSERVED TO SLOWING DRIFT DURING DELIVERY. SPECIFICALLY WHEN DELIVERING 60W OF MEDIUM CUT OUTPUT POWER IN THE SERVICE DEPARTMENT; UNIT WOULD START NEAR THE TOP OF ITS ALLOWABLE RANGE AND THEN DRIFT UP THE LONGER IT WAS KEYED. IT WOULD EXCEED THE MAXIMUM ALLOWABLE POWER LEVEL (RATED POWER +20%) AFTER ABOUT 10 SECONDS. WHEN KEYED AGAIN IMMEDIATELY, THE UNIT WOULD RESUME AT A HIGH POWER LEVEL. IT WOULD TAKE ABOUT A MINUTE OF THE MACHINE BEING LEFT IDLE (POWERED UP BUT UN-KEYED) BEFORE THE INITIAL POWER WOULD START BACK AT THE ORIGINAL STARTING POWER LEVEL. DEBUG OF SYSTEM REVEALED THAT OPTOCOUPLER U57 ON THE RF AMP PCBA WAS NON-FUNCTIONAL. THIS PREVENTED RELIABLE DRIVE OF OUTPUT POWER TRANSFORMER T3 AND RESULTED IN THE UNUSUAL BEHAVIOR. ROOT CAUSE: THE SYSTEM WAS RETURNED WITHOUT COMPLAINT. INCOMING TEST REVEALED THAT THE OUTPUT POWER WAS DRIFTING IN MEDIUM CUT MODE. THIS BEHAVIOR WAS TRACED TO NON-FUNCTIONAL COMPONENT U57 ON THE RF AMP PCBA. THE DHR FOR THE UNIT SHOWS THAT THE POWER WAS NOT DRIFTING DURING BURN-IN TESTING WHEN THE UNIT WAS MANUFACTURED. THERE IS SUFFICIENT OBJECTIVE EVIDENCE TO DETERMINE THE CAUSE OF FAILURE FOR COMPONENT U57. (B)(4).

    Description of Event or Problem · 1

    SERVICE INITIATED COMPLAINT: GENERATOR 14C22411 WAS RETURNED ((B)(4) 2014) AS PART OF AN EXIT AUDIT, NO ISSUES REPORTED. SERVICING DISCOVERED AND REPORTED THAT THE GENERATOR OUTPUT POWER IN MEDIUM CUT MODE WAS OBSERVED TO SLOWLY DRIFT HIGHER DURING ACTIVATION TO THE POINT WHERE THE OUTPUT VALUES ROSE ABOVE THE MAXIMUM VALUE. NO PATIENT INVOLVEMENT OR IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97863 GENERATOR PULSAR II ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-102

    Patients

    Seq Age Sex Outcome Treatment
    1