BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROTORQUE PLUS

    MDR report key: 774627 · Received October 26, 2006

    Report

    Report Number
    1419798-2006-00006
    Event Type
    Injury
    Date Received
    October 26, 2006
    Date of Event
    August 10, 2006
    Report Date
    September 27, 2006
    Manufacturer
    KAVO AMERICA
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    TWO HAND PIECES WERE RECEIVED FROM THE DENTAL OFFICE. IT WAS REPORTED BY THE DENTAL OFFICE THAT IT IS UNCERTAIN WHICH HANDPIECE WAS ASSOCIATED WITH THE INCIDENT. VISUAL INSPECTION REVEALED THAT BEARINGS WERE WORN AND GRITTY IN THE DRIVE ASSEMBLY AND SHAFT. THE WATER PORTS WERE OBSERVED TO BE CLOGGED AND THE CHUCK WAS NOTED TO SLIP. A MODERATE LEVEL OF DEBRIS WAS OBSERVED INSIDE THE HANDPIECE. VISUAL INSPECTION REVEALED THAT THE BEARINGS WERE WORN AND GRITTY IN THE DRIVE ASSEMBLY. THE WATER PORTS WERE OBSERVED TO BE CLOGGED. A HIGH LEVEL OF DEBRIS WAS OBSERVED INSIDE 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 HANDPIECE CAN POTENTIALLY GENERATE FRICTIONAL HEAT CAPABLE OF CAUSING SERIOUS BURN INJURIES TO THE PATIENT. IT ALSO STATES THAT PRESSURE SHOULD NOT BE APPLIED TO THE CHUCK RELEASE BUTTON WHILE THE HANDPIECE IS ROTATING; THIS INCLUDES USING THE HEAD OF THE ATTACHMENT AS A CHEEK OR TONGUE RETRACTOR.

    Description of Event or Problem · 1

    A DENTIST REPORTED THAT A PATIENT RECEIVED A BURN ON THE INSIDE OF HER CHEEK NEAR TOOTH NUMBER 18, DURING THE USE OF A 25LHA HANDPIECE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS, "CANALOGAN" IN ORALBASE AND PROVIDED WITH A DEXAMETHASONE ORAL RINSE. IT WAS REPORTED THAT THE PT RETURNED TO THE DENTAL OFFICE IN 2006, FOR FOLLOW UP AND THE PATIENT HAD RECOVERED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other