BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LPR

    MDR report key: 5010414 · Received August 18, 2015

    Report

    Report Number
    3003637274-2015-00021
    Event Type
    Injury
    Date Received
    August 18, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 20, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EKX
    PMA / PMN Number
    K073478
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE TEST RUN DURING THE ANALYSIS OF THE REPAIR DID SHOW THAT THE HEAD HEATED UP QUICKLY. THE ROOT CAUSE WAS THAT THE HEAD HAD A DENT WHICH CAUSED THE PUSH BUTTON TO STICK IN, RUBBING ON THE DRIVE ASSEMBLY CAUSING UNUSUAL FRICTION AND THEREFORE INCREASE OF TEMPERATURE. THE DENT SHOWS THAT THE HANDPIECE RECEIVED A STRONG HIT FROM OUTSIDE, E.G. DUE TO A DROP. THE TEST RUN DID ALSO SHOW THAT THE CURRENT CONSUMPTION WAS OUT OF SPECIFICATION. ROOT CAUSE WAS ON ONE HAND THE RUBBING PUSH BUTTON BUT ON THE OTHER HAND THE CONDITION OF THE BEARINGS. THEY HAVE BEEN FOUND GRITTY AFTER DISASSEMBLING THE HANDPIECE WHICH CAUSED IN ADDITION HIGHER FRICTION AND HENCE INCREASE OF TEMPERATURE. TO AVOID SUCH ISSUES THE USER INSTRUCTION CONTAINS ALREADY SEVERAL NOTES, WARNINGS AND REQUESTS HOW TO PREPARE THE HANDPIECE FOR EACH TREATMENT: 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 PUSHBUTTON 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

    WHILE WORKING ON TOOTH# 30 THE HANDPIECE HEATED UP AND BURNED THE PATIENT ON CHEEK . THE DENTIST PRESCRIBED VICOPROFEN AND GAVE SOME VITAMINE E OINTMENT TO THE PATIENT TO APPLY TO BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545946 GENTLEPOWER LUX CONTRA ANGLE 25LPR ELECTRICAL DENTAL HANDPIECE EKX KAVO DENTAL GMBH 25 LPR

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other