BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDPIECE 1897200 MAGNUM II HI SPEED EN

    MDR report key: 2635697 · Received June 29, 2012

    Report

    Report Number
    1045254-2012-00376
    Event Type
    Malfunction
    Date Received
    June 29, 2012
    Report Date
    May 31, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    EQJ
    PMA / PMN Number
    K002224
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS ANALYZED. ON (B)(4) 2012, THE ENGINEERING GROUP EVALUATED THE CUSTOMER'S RETURNED SYSTEM, INCLUDING THE XPS 3000 CONSOLE, THE MAGNUM 2 (M2) HANDPIECE, AND THE TWO-PEDAL XPS FOOTSWITCH. THE EVALUATION WAS CONDUCTED IN (B)(4) SERVICE & REPAIR AREA. IT WAS NOTED THAT THE CONNECTOR ON THE M2 HANDPIECE WAS WORN. THE HANDPIECE WAS PLUGGED INTO THE CONSOLE AND ATTEMPTED TO RUN IN OSCILLATE MODE AT 5000 RPM USING THE CONSOLE'S MANUAL RUN SWITCH; THE HANDPIECE DID NOT RUN. THE INNER PORTION OF A TEST BLADE (PROVIDED BY S & R) WAS INSERTED INTO THE HANDPIECE AND IT WAS ATTEMPTED TO MANUALLY ROTATE THE MOTOR; THE MOTOR DID NOT ROTATE. BASED ON THESE OBSERVATIONS, THE MOTOR HAD SEIZED. A TEST HANDPIECE (PROVIDED BY S & R) WAS USED TO FURTHER EVALUATE THE CONSOLE AND FOOTSWITCH. THE FOOTSWITCH AND M4 WERE PLUGGED INTO THE CONSOLE. THE RUN PEDAL WAS DEPRESSED AND THE HANDPIECE BEGAN TO RUN (DEFAULT RUN SETTINGS WERE USED). WHEN THE PEDAL WAS RELEASED, THE HANDPIECE CONTINUED RUNNING AT 60 RPM. THE PORTION OF THE CABLE NEAREST THE FOOTSWITCH THAT IS COVERED BY HEAT SHRINK WAS FLEXED BACK AND FORTH, AND THE SPEED OF THE HANDPIECE WOULD INTERMITTENTLY CHANGE BETWEEN 60 AND 5000 RPM EVEN WHEN THE PEDAL WAS NOT DEPRESSED. INTERNAL ISSUES IN THE HANDPIECE THAT CAUSE MOTOR SEIZURE CAN ALSO CAUSE THE HANDPIECE TO OVERHEAT. BASED ON THIS AND THE OTHER OBSERVATIONS DURING THE INITIAL EVALUATION, THE COMPLAINT IS CONSIDERED CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY PREPARATION OF THE PATIENT, THE UNIT (HANDPIECE) RAN HOT AND BURNT THE NURSE. THE NURSE RECEIVED A SMALL BLISTER AND AN ICE PACK WAS PLACED ON IT. NO INTERVENTION WAS NECESSARY. NO IMPACT OR INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANDPIECE 1897200 MAGNUM II HI SPEED EN BUR, EAR, NOSE AND THROAT EQJ MEDTRONIC XOMED, INC. 1897200 31684100

    Patients

    Seq Age Sex Outcome Treatment
    1 XPS FOOTSWITCH AND XPS CONSOLE| XPS 3000 CONSOLE: (B)(4), XPS FOOTSWITCH: (B)(4)