BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORTDRIVE 200XDR

    MDR report key: 5229107 · Received November 17, 2015

    Report

    Report Number
    3003637274-2015-00031
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    October 7, 2015
    Report Date
    November 2, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EKX
    PMA / PMN Number
    K080677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING A SHORT TEST RUN THE HEAT UP OF THE HANDPIECE HAS BEEN REPRODUCIBLE. ROOT CAUSE IS THAT THE BEARINGS HAVE BEEN GRITTY. THIS CAUSES HIGHER FRICTION AND THEREFORE INCREASE OF TEMPERATURE. ROOT CAUSE IS THAT THE BEARINGS ARE CONTENT OF A NORMAL WEAR PROCESS. THE HANDPIECE HAS NOT BEEN SENT IN FOR REPAIR SINCE THE PURCHASE IN (B)(6) 2011. THE ANALYSIS DID ALSO SHOW THAT THE PUSH BUTTON HAS CIRCULAR GROOVES ON THE INNER SIDE. THIS SHOWS THAT IT HAS BEEN PRESSED WHILE THE TOOL HAS BEEN SPINNING. ROOT CAUSE IS THAT THE HANDPIECE HAS BEEN USED AS A CHEEK RETRACTOR. THE IFU CONTAINS SEVERAL NOTES AND WARNINGS TO AVOID SUCH INCIDENTS: 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. (B)(4).

    Description of Event or Problem · 1

    OVER A COUPLE OF MONTHS SEVERAL PATIENTS HAVE BEEN COMPLAINING THAT THE HANDPIECE WAS GETTING HOT TO LIP OR CHEEK DURING THE TREATMENT. NOBODY WAS INJURED. NOBODY IN THE DENTAL OFFICE DOES RECALL WHICH PATIENTS COMPLAINED ABOUT HEAT THEREFORE IT IS NOT POSSIBLE TO SUPPLY DETAILS ABOUT PATIENTS AND THE 'DATE OF EVENT' IS BEST ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760302 COMFORTDRIVE 200XDR DENTAL HANDPIECE EKX KAVO DENTAL GMBH 200XDR

    Patients

    Seq Age Sex Outcome Treatment
    1