BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROTORQUE PLUS

    MDR report key: 768383 · Received October 6, 2006

    Report

    Report Number
    1419798-2006-00004
    Event Type
    Injury
    Date Received
    October 6, 2006
    Date of Event
    August 31, 2006
    Report Date
    September 8, 2006
    Manufacturer
    KAVO DENTAL
    Product Code
    EKK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL UNIT ASSOCIATED WITH THE INCIDENT WAS RETURNED TO THE MFR FOR ANALYSIS. VISUAL INSPECTION OF THE UNIT REVEALED THAT THE HEAD WAS DENTED AT THE BACK CAP AND IN SEVERAL PLACES AROUND THE WATER SPRAY PLATE. THE BEARINGS WERE NOTED TO GRIND AND HEAT UP UPON OPERATION OF THE UNIT. THE UNIT WAS DISASSEMBLED FOR FURTHER ANALYSIS AND LIGHT RESIDUE INSIDE THE UNIT WAS OBSERVED. 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 PT. 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 PT RECEIVED A BURN TO HIS TONGUE DURING THE USE OF A 25LPA HANDPIECE. THE PT WAS PRESCRIBED AN ANTIBIOTIC AND TYLENOL. IT WAS REPORTED THAT THE PT HAS SINCE 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