BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL

    MDR report key: 1506402 · Received September 22, 2009

    Report

    Report Number
    1045254-2009-00037
    Event Type
    Malfunction
    Date Received
    September 22, 2009
    Date of Event
    August 25, 2009
    Report Date
    August 25, 2009
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ERL
    PMA / PMN Number
    K041523
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS BY MEDTRONIC CONCLUDED THAT THE HANDPIECE (B) (4) (REF. MANUFACTURER REPORT # 1045254-2009-00038) AND THE FOOTSWITCH (B) (4) BOTH CONTRIBUTED TO THE EVENT. FUNCTIONAL TESTING FOUND THE HANDPIECE DID NOT TURN WHEN ACTIVATED USING THE FOOTSWITCH OR THE MANUAL BUTTON, YET THE DISPLAY SCREEN SHOWED 60 RPM. IT WAS VERIFIED THAT THE HANDPIECE MOTOR WAS SEIZED. IT WAS ALSO VERIFIED THAT THE FOOTSWITCH WILL SIGNAL TO RUN THE HANDPIECE AT 60 RPM INTERMITTENTLY WITHOUT BEING PRESSED. THE HEAT WAS CAUSED BY CURRENT BEING DELIVERED TO A HANDPIECE WITH A LOCKED UP MOTOR. THE OVERHEATING FAULT CAN ONLY BE REPRODUCED IF THE FOLLOWING DOUBLE FAULT SITUATION EXISTS; IF THE HANDPIECE HAS A LOCKED UP MOTOR, AND THERE IS AN ELECTRICAL FAULT IN THE FOOTSWITCH. TO ENSURE THAT THIS FAULT WAS NOT SYSTEMIC, A NEW FOOTSWITCH WAS USED AND THIS FAULT COULD NOT BE REPRODUCED. THERE WAS NO DELAY OF SURGERY AND THERE WAS NO IMPACT TO THE PATIENT. WE ARE FILING THIS REPORT BASED ON, IF THE MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE SYSTEM'S INSTRUCTIONS FOR USE WARNS THAT: "WHEN NOT OPERATING HANDPIECE, ENSURE THE HANDPIECE RESTS ON A NON-CONDUCTIVE SURFACE THAT PROVIDES CONTAINMENT FOR HANDPIECE AND BUR/BLADE. AVOID UNINTENDED THERMAL INJURY BY AN UNCONTAINED HANDPIECE. ALWAYS INSPECT THE COMPONENTS BEFORE AND AFTER USE FOR ANY DAMAGE." THE HANDPIECE HAS BEEN IN USE AT THE FACILITY FOR 3.5 YEARS, THE FOOTSWITCH FOR 20 MONTHS, WITH NO PRIOR REQUESTS MADE FOR SERVICE OR REPAIR. A MEDWATCH FORM WAS NOT RECEIVED FROM THE REPORTER, THEREFORE, ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. THIS PRODUCT WAS NOT BEING USED FOR DIAGNOSIS.

    Description of Event or Problem · 1

    THE SCRUB NURSE PREPARED THE HANDPIECE BY ATTACHING THE IRRIGATION AND SUCTION TUBING. THE HANDPIECE WAS ACTIVATED ONLY TO PRIME THE IRRIGATION TUBING. HANDPIECE WAS THEN PLACED ON TOP OF A FOLDED TOWEL ON THE PATIENT. THE SCRUB BEGAN TO SMELL SOMETHING AND LOOKED FOR THE SOURCE. THE HANDPIECE WAS IDENTIFIED AND WHEN AN ATTEMPT WAS MADE TO MOVE THE HANDPIECE, IT WAS TOO HOT TO TOUCH. HANDPIECE WAS REMOVED FROM THE FIELD, A DIFFERENT HANDPIECE ATTACHED AND USED WITHOUT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOOTSWITCH 1895420 XPS MULTIFUNCTIONAL 77ERL ERL MEDTRONIC XOMED, INC. 1895420 53780700

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR