BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMFORTDRIVE 200XDR

    MDR report key: 4804075 · Received May 29, 2015

    Report

    Report Number
    3003637274-2015-00010
    Event Type
    Injury
    Date Received
    May 29, 2015
    Date of Event
    April 2, 2015
    Report Date
    April 20, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EKX
    PMA / PMN Number
    K080677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DID SHOW THAT THE PUSH BUTTON OF THE HANDPIECE'S HEAD STUCK IN DUE TO A DENT IN THE HEAD. THE PUSH BUTTON HAS TO BE PRESSED TO INSERT OR REMOVE A TOOL (E.G. A BUR). IF IT STICKS IN IT CAUSES UNUSUAL INNER FRICTION AND RUBS ON MOVING PARTS WHICH CAUSES A QUICK HEAT UP OF THE PUSH BUTTON AND THE HEAD. THE DENT IS A SIGN THAT THE HEAD RECEIVED A STRONG HIT, E.G. A DROP DURING REPROCESSING. THE INSTRUCTION FOR USE CONTAINS SEVERAL WARNINGS AND NOTES TO INFORM ABOUT THE RISKS AND HOW TO AVOID THEM: 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 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. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: TO BE CONFIRM WITH FDA-REQUEST WE HEREWITH SUPPLY FOLLOWING INFORMATION WHICH WE MISSED IN THE ORIGINAL MDR: EXEMPTION NUMBER E2010020. (B)(4). CORRECTION: WE RECOGNIZED THAT THE MANUFACTURER REPORT NUMBER IN THE ORIGINAL REPORT WAS NOT FULLY DISPLAYED, THEREFORE WITH THIS FOLLOW-UP THE MFR REPORT # IS CORRECTED.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HANDPIECE HEATED UP AND CAUSED A BURN ON PATIENTS CHEEK INSIDE THE MOUTH. THE SIZE WAS BETWEEN A DIME AND A NICKLE. THE PATIENT WAS PRESCRIBED PERIO SCIENCE ANTIBACTERIAL OINTMENT TO APPLY TO BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351167 COMFORTDRIVE 200XDR ELECTRICAL DENTAL HANDPIECE EKX KAVO DENTAL GMBH 200XDR

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other