BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPR

    MDR report key: 5090845 · Received September 21, 2015

    Report

    Report Number
    3003637274-2015-00025
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Date of Event
    August 31, 2015
    Report Date
    September 8, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EKX
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS OF THE HANDPIECE SHOWED THAT IT WAS RUNNING OUT OF SPECIFICATION. THIS MEANS THAT THE CURRENT CONSUMPTION DURING THE TEST RUN WAS HIGHER THAN SPECIFIED. ROOT CAUSE IS THAT THE INNER PARTS ARE RUNNING STIFF DUE TO WORN BEARINGS. THE HEAT UP WAS REPRODUCIBLE DURING THE TEST RUN. IT ALSO SHOWED THAT THE PUSH BUTTON HAD CIRCULAR WARE MARKS ON THE INNER SIDE. THIS SHOWS THAT IT HAS BEEN PRESSED WHILE HANDPIECE WAS RUNNING. THIS IS NORMALLY THE CASE WHEN IT IS USED TO LIFT THE CHEEK OR TONGUE AWAY. TO AVOID SUCH ISSUES THE USER INSTRUCTION CONTAINS SEVERAL WARNINGS AND NOTES: 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. 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 PUSH BUTTON DURING OPERATION. THIS ALSO INCLUDES LIFTING THE CHEEK OR TONGUE! 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. (B)(4).

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HANDPIECE HEATED UP AND BURNED THE PATIENT ON INNER CHEEK. THERE WAS NO MEDICAL CARE NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622311 GENTLEPOWER LUX CONTRA ANGLE 25LPR ELECTRICAL DENTAL HANDPIECE EKX KAVO DENTAL GMBH 25 LPR

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR