BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORTDRIVE 200XDR

    MDR report key: 4472651 · Received February 2, 2015

    Report

    Report Number
    3003637274-2015-00001
    Event Type
    Malfunction
    Date Received
    February 2, 2015
    Date of Event
    January 13, 2015
    Report Date
    January 19, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EFB
    PMA / PMN Number
    K080677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE TEST RUN THE HEAT UP OF THE HANDPIECE HAS BEEN REPRODUCIBLE. THE ANALYSIS DID SHOW THAT STATOR AND AXLE RAN BAD, THEREFORE THE INTERMEDIATE PART AND THE DRIVE HAVE BEEN RUNNING SLOW. THE IFU CONTAINS SEVERAL NOTES AND WARNINGS TO AVOID THAT HANDPIECES WHICH ARE RUNNING OUT OF SPECIFICATION GET USED FOR TREATMENTS: 1) WARNING: HAZARDS FOR THE CARE PROVIDER AND THE PATIENT. IN THE CASE OF DAMAGE, IRREGULAR RUNNING NOISE, EXCESSIVE VIBRATION, UNTYPICAL WARMING OR WHEN THE CUTTER OR GRINDER CANNOT BE HELD. -> DO NOT USE FURTHER AND NOTIFY SERVICE. 2) CAUTION: BURNING HAZARD FROM HOT INSTRUMENT HEAD OR HOT INSTRUMENTS COVER. IF THE INSTRUMENT OVERHEATS, BURNS MAY ARISE IN THE ORAL AREA. -> NEVER CONTACT SOFT TISSUE WITH THE INSTRUMENT HEAD OR INSTRUMENT COVER. 3) CAUTION: HAZARD FROM THE USE OF HANDPIECES EQUIPPED WITH ELECTRONIC MICROMOTORS. ELECTRONIC MICROMOTORS GENERATE MUCH MORE ENERGY THAN CONVENTIONAL PNEUMATIC TURBINES AND MOTORS. GIVEN THE HIGHER TORQUE AND SPEED, HANDPIECES THAT ARE POORLY SERVICED, DAMAGED OR USED IMPROPERLY CAN OVERHEAT WHICH CAN CAUSE SERIOUS BURN INJURIES TO THE PATIENT. -> OBSERVE THE FOLLOWING POINTS. THE FOLLOWING GUIDELINES MUST BE OBSERVED TO ENSURE SAVE USE OF THE ELECTRICALLY DRIVEN HANDPIECES: * THE SERVICE INSTRUCTIONS FOR HANDPIECES MUST BE PRECISELY FOLLOWING WHEN USING KAVO SPRAY OR QUATTROCARE CARE SYSTEMS. * BEFORE EACH USE, THE HANDPIECE MUST BE CHECKED FOR EXTERNAL DAMAGE. * BEFORE EACH USE, PERFORM A TEST RUN WITH THE HANDPIECE, AND WATCH FOR ATYPICAL HEATING AND UNUSUAL NOISE AND VIBRATION. * IMMEDIATELY STOP USING HANDPIECES THAT ACT UNUSUAL. * NEVER PRESS THE PUSHBUTTON DURING OPERATION. THIS ALSO INCLUDES LIFTING THE CHEEK OR TONGUE! WE RECOMMEND RETURNING THE HANDPIECES TO KAVO AT REGULAR INTERVALS FOR TESTING, SETUP AND SERVICING. THE FREQUENCY OF THE CARE DEPENDS ON THE INSTRUMENTS USE. THE CONTRA-ANGLE HANDPIECES MUST BE SETUP ACCORDING TO THE KAVO INSTRUCTIONS TO ENSURE PROPER FUNCTIONING.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HANDPIECE BECAME HOT AND BURNED THE PATIENT ON LOWER LIP TO THE SIZE OF THE BACK CAP. PATIENT WAS TOLD TO APPLY OTC VASELINE TO THE LIP. NO MEDICAL CARE WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73884 COMFORTDRIVE 200XDR DENTAL HANDPIECE EFB KAVO DENTAL GMBH 200XDR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR