BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEAK PLASMA BLADE

    MDR report key: 3222187 · Received July 9, 2013

    Report

    Report Number
    3222187
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 6, 2013
    Report Date
    July 9, 2013
    Manufacturer
    MEDTRONIC ADVANCED ENERGY
    Product Code
    DWG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    DR STARTED USING THE PEAK PLASMA BLADE AND STATED THAT AFTER 1-2 SECONDS, HE NOTICED A CHANGE OF COLOR ON THE PLASTIC TIP OF THE BLADE. HE TOOK THE BLADE OUT OF THE PATIENT'S MOUTH AND TESTED THE BLADE BY STEPPING ON THE FOOT PEDAL. DR NOTICED A "CANDLE" FLAME AND NOTIFIED THE CIRCULATOR WITH THE CASE. THE RN STATED THAT SHE/HE SAW A FLAME AND IMMEDIATELY TURNED OFF THE MACHINE AND UNPLUGGED THE CORE OF THE HANDPIECE. SHE/HE STATED THAT THE FLAME DISAPPEARED RIGHT AWAY BUT THERE WAS SOME SMOKE. THE CIRCULATING NURSE OPENED ANOTHER STERILE HAND PIECE AND RECONNECTED IT TO THE MACHINE. THE SURGERY CONTINUED AND THE PATIENT WAS EXAMINED BY DR AND ANESTHESIOLOGIST. THERE WAS NO EVIDENCE OF PATIENT INJURY.SALES REP RESPONDED RIGHT AWAY TO THE ISSUE. REPORTED TO THE COMPANY, ORDERED NEW EQUIPMENT, AND REPLACED DISPOSABLES WITH SAME LOT NUMBERS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?BILATERAL TONSILLECTOMY AND ADENODECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313583 PEAK PLASMA BLADE ELECTROSURGICAL DEVICE DWG MEDTRONIC ADVANCED ENERGY PS300-002 58213

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR NO OTHER THERAPIES