BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMFORTDRIVE 200XDR

    MDR report key: 7702170 · Received July 19, 2018

    Report

    Report Number
    3003637274-2018-00032
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Date of Event
    May 22, 2018
    Report Date
    July 19, 2018
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EKX
    PMA / PMN Number
    K080677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN ANALYSIS OF THE PRODUCT WAS NOT POSSIBLE AS THE DENTIST DID NOT SEND IN THE PRODUCT. DURING CONVERSATION BY EMAIL AND PHONE IT WAS STATED THAT THE PRODUCT WAS REPAIRED AT LOCAL REPAIR SHOPS WHICH ARE UNKNOWN TO KAVO. THEREFORE, IT IS NOT KNOWN IF THE PRODUCT WAS REPAIRED WITH ORIGINAL SPARE PARTS OR IF THIRD PARTY PARTS HAVE BEEN USED. IN ADDITION IT WAS STATED THAT THE HANDPIECE WAS USED TO RETRACT THE LIP FROM THE TREATMENT AREA WHICH IS A USE AGAINST THE IFU. TO AVOID SUCH ISSUES THE USER INSTRUCTION CONTAINS ALREADY SEVERAL NOTES, WARNINGS AND REQUESTS HOW TO PREPARE THE HANDPIECE FOR EACH TREATMENT AND HOW TO USE IT: 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 CONTRA-ANGLE HANDPIECES: THE SERVICE INSTRUCTIONS FOR CONTRA-ANGLE HANDPIECES MUST BE PRECISELY FOLLOWING WHEN USING KAVO SPRAY OR QUATTROCARE CARE SYSTEMS. BEFORE EACH USE, THE CONTRA-ANGLE HANDPIECE MUST BE CHECKED FOR EXTERNAL DAMAGE. BEFORE EACH USE, PERFORM A TEST RUN WITH THE CONTRA-ANGLE HANDPIECE, AND WATCH FOR ATYPICAL HEATING AND UNUSUAL NOISE AND VIBRATION. IMMEDIATELY STOP USING CONTRA-ANGLE 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. THE FOLLOWING INDIVIDUALS ARE AUTHORIZED TO REPAIR AND SERVICE KAVO PRODUCTS: TECHNICIANS AT KAVO BRANCHES THROUGHOUT THE WORLD. TECHNICIANS SPECIALLY TRAINED BY KAVO. TO ENSURE PROPER FUNCTION, THE MEDICAL DEVICE MUST BE SET UP ACCORDING TO THE REPROCESSING METHODS DESCRIBED IN THE KAVO INSTRUCTIONS FOR USE, AND THE CARE PRODUCTS AND CARE SYSTEMS DESCRIBED THEREIN MUST BE USED. KAVO RECOMMENDS SPECIFYING A SERVICE INTERVAL AT THE DENTAL OFFICE FOR A LICENSED SHOP TO CLEAN, SERVICE AND CHECK THE FUNCTIONING OF THE MEDICAL DEVICE. THIS SERVICE INTERVAL DEPENDS ON THE FREQUENCY OF USE AND SHOULD BE ADJUSTED ACCORDINGLY. SERVICE MAY ONLY BE CARRIED OUT BY KAVO-TRAINED REPAIR SHOPS USING ORIGINAL KAVO REPLACEMENT PARTS. (B)(4).

    Description of Event or Problem · 1

    (B)(6) INFORMED BY EMAIL THAT DURING A PATIENT PROCEDURE ON (B)(6) 2018 THE PATIENT WAS BURNED ON RIGHT CORNER OF LIP. HE STATED THE PATIENT HAD A FULL RECOVERY AND FELT NO PAIN AFTER 24 HOURS. NO OINTMENT OR MEDICATION GIVEN TO PATIENT FOR BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544074 COMFORTDRIVE 200XDR DENTAL ELECTRICAL HANDPIECE EKX KAVO DENTAL GMBH 200XDR

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR