BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERATOR PULSAR

    MDR report key: 5650164 · Received May 12, 2016

    Report

    Report Number
    1226420-2016-00050
    Event Type
    Malfunction
    Date Received
    May 12, 2016
    Date of Event
    April 12, 2016
    Report Date
    April 13, 2016
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT #(B)(4) EVALUATION PROCESS: PERFORMED VISUAL INSPECTION IAW (B)(4) -HEAVY CASE STAINING -LOWER CASE BENT/TWISTED; UPPER CASE BENT AT REAR LEFT CORNER -LEFT TRIM PIECE BROKEN -POWER ROCKER SWITCH HOUSING CRACKED -BOTH NYLON SCREWS IN BASE BROKEN -DC PCBA FRONT NYLON STANDOFF BROKEN -NYLON SCREW SECURING RF MODULE FRONT LONG BUMPER BROKEN -ULTRAVOLT NEGATIVE CONTROL HARNESS DISCONNECTED FROM ULTRAVOLT POWER SUPPLY (RECONNECTED AT TIME OF DISCOVERY) PERFORMED BASELINE PERFORMANCE TESTING IAW (B)(4): -HANDPIECE CUT BUTTON FUNCTION INOPERATIVE. HANDPIECE COAG FUNCTION ENABLES RF OUTPUT BUT OUTPUT WILL NOT CEASE WHEN BUTTON IS RELEASED. (FOOTSWITCH OPERATION WAS NORMAL) -PHYSICAL DAMAGE IDENTIFIED HAD NO IMPACT TO FUNCTIONALITY OF THE UNIT ROOT CAUSE: -THE HANDPIECE BUTTON OPERATION MALFUNCTIONS WERE CAUSED BY A FAULTY NPN TRANSISTOR (Q22) ON THE RF AMPLIFIER PCBA. IT FAILED SUCH THAT, UPON ACTIVATION OF THE COAG HANDPIECE BUTTON, THE COAG BUTTON APPEARED TO BE CONTINUOUSLY BEING HELD DOWN EVEN AFTER IT WAS RELEASED. REPLACEMENT OF THE TRANSISTOR RETURNED THE UNIT TO FULL FUNCTIONALITY. -THE PHYSICAL DAMAGE IS CONSISTENT WITH ROUGH HANDLING IN THE FIELD. -THE CASE STAINING IS DUE TO THE USE OF AGGRESSIVE CLEANING AGENTS IN THE FIELD AND DOES NOT AFFECT SYSTEM PERFORMANCE. -THE UCB REAL-TIME CLOCK BATTERY DIED DUE TO AGE. THE DEAD BATTERY RESULTS IN A RESETTING OF THE SYSTEM CLOCK TO 12:00AM (B)(6) 2003 WHICH RESULTS IN INACCURATE TIME STAMPING OF ATTACHED DEVICES AND PREVENTS DETECTION OF EXPIRED DEVICES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING SET UP FOR A PROCEDURE THE STAFF ACTIVATED THE COAG FUNCTION ON THE DEVICE AND REPORTED AFTER RELEASING THE COAG ACTIVATION BUTTON RF ENERGY WAS STILL BEING DELIVERED. THE BIOMED DEPARTMENT TESTED TWO OTHER DEVICES AND THE ISSUE RECURRED. THEY ALSO REPORTED NO RF ENERGY WAS DELIVERED TO THE DEVICE WHEN THE CUT FUNCTION WAS ACTIVATED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305170 GENERATOR PULSAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI MEDTRONIC ADVANCED ENERGY, LLC PS100-100

    Patients

    Seq Age Sex Outcome Treatment
    1