BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORTDRIVE 200XDR

    MDR report key: 9680462 · Received February 7, 2020

    Report

    Report Number
    3003637274-2015-00002
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    March 11, 2015
    Report Date
    April 2, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EKX
    PMA / PMN Number
    K080677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ANALYSIS OF THE PRODUCT IT WAS FOUND THAT THE HEAD HAD A DENT. THIS CAUSED THE BACK CAP TO STICK IN AFTER INSERTING THE BUR. THE RESULT WAS UNUSUAL INNER FRICTION AND HENCE THE HEAT UP OF THE HEAD. THE DENT SHOWS THAT THE HANDPIECE RECEIVED A STRONG HIT, E.G. A DROP DURING REPROCESSING. THE IFU CONTAINS SEVERAL NOTES AND WARNINGS TO AVOID THAT HANDPIECES WHICH ARE RUNNING OUT OF SPECIFICATION GET USED FOR TREATMENTS: 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. 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. 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 PUSH BUTTON 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. EXEMPTION NUMBER E2010020. KAVO DENTAL GMBH GERMANY (THE MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF KAVO DENTAL USA (THE IMPORTER). [(B)(4)].

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HANDPIECE HEATED UP AND CAUSED A BURN ON THE PATIENTS TONGUE WITH THE SIZE OF A QUARTER. DOCTOR DECIDED TO PERFORM A DIODE LASER TREATMENT TO HELP HEALING. PATIENT WAS PRESCRIBED AO PROVANTAGE ANTIOXIDANT GEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143950 COMFORTDRIVE 200XDR DENTAL HANDPIECE EKX KAVO DENTAL GMBH 200XDR

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other