BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROTORQUE PLUS

    MDR report key: 766022 · Received September 27, 2006

    Report

    Report Number
    1419798-2006-00002
    Event Type
    Injury
    Date Received
    September 27, 2006
    Date of Event
    August 21, 2006
    Report Date
    August 28, 2006
    Manufacturer
    KAVO DENTAL
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL UNIT INVOLVED IN THE INCIDENT WAS RETURNED FOR EVALUATION. IT WAS OBSERVED THAT THE HAD DENTS AT THE 1 AND 9 O'CLOCK POSITIONS ON THE WATER FACEPLATE AND AT THE 1 AND 10 O'CLOCK POSITIONS ON THE BACK END CAP. IT WAS OBSERVED THAT THE HEAD, INSERT, DRIVE ASSEMBLY AND COVER NUT ARE ALL DAMAGED DUE TO THE MULTIPLE DENTS IN THE HEAD. THE UNIT WAS DISASSEMBLE FOR FURTHER INSPECTION. IT WAS OBSERVED THAT THE BEARINGS AND SHAFT IN THE DRIVE ASSEMBLY ARE WORN AND GRITTY DUE TO THE MULTIPLE DENTS. A HIGH AMOUNT OF DEBRIS WAS ALSO OBSERVED IN THE HANDPIECE. DURING A FOLLOW UP CALL WITH THE DENTAL OFFICE BY THE MANUFACTURER, IT WAS REPORTED THAT THE HANDPIECE MAY NOT HAVE BEEN MAINTAINED ACCORDING TO THE MANUFACTURER'S RECOMMENDATIONS. IT WAS REPORTED THAT THE HANDPIECE IS NOT CLEARED OF DEBRIS UNTIL AFTER THE UNIT HAS BEEN REMOVED FROM THE AUTOCLAVE. THE DENTAL OFFICE WAS ADVISED THAT PERFORMING THIS PRACTICE MAY CAUSE THE DEBRIS TO BECOME BAKED INSIDE THE HANDPIECE. THE OFFICE WAS REEDUCATED AS TO THE PROPER MAINTENANCE OF THE HANDPIECE AND WAS PROVIDED WITH MAINTENANCE INSTRUCTIONS. A CAUTIONARY STATEMENT IS INCLUDED WITH EACH UNIT WHICH STATES THAT ELECTRIC MICROMOTORS GENERATE SIGNIFICANTLY MORE POWER THAN TRADITIONAL AIR TURBINES AND AIR MOTORS. DUE TO INCREASED TORQUE AND SPEED, POORLY MAINTAINED, DAMAGED OR MISUSED HANDPIECES CAN POTENTIALLY GENERATE FRICTIONAL HEAT CAPABLE OF CAUSING SERIOUS BURN INJURIES TO THE PATIENT. IT ALSO STATES THAT THE HEAD OF THE ATTACHMENT SHOULD NOT BE USED AS A CHEEK OR TONGUE RETRACTOR.

    Description of Event or Problem · 1

    A DENTIST REPORTED THAT A PATIENT RECEIVED A BURN TO HIS CHEEK DURING THE USE OF A 25LPA HANDPIECE. THE PATIENT WAS PRESCRIBED KENALOG IN ORABASE TO TREAT THE PATIENT'S BURN. IT WAS REPORTED THAT THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROTORQUE PLUS ELECTRIC DENTAL HANDPIECE EKK KAVO DENTAL 25LPA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other