BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTLEPOWER LUX CONTRA ANGLE 25LP

    MDR report key: 4994792 · Received August 12, 2015

    Report

    Report Number
    3003637274-2015-00022
    Event Type
    Malfunction
    Date Received
    August 12, 2015
    Date of Event
    July 1, 2015
    Report Date
    July 13, 2015
    Manufacturer
    KAVO DENTAL GMBH
    Product Code
    EKX
    PMA / PMN Number
    K073478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ANALYSIS DURING THE REPAIR DID SHOW THAT THE BEARINGS OF THE DRIVE ASSEMBLY HAVE BEEN WORN OUT. THIS CAUSES HIGHER FRICTION AND THEREFORE INCREASE OF TEMPERATURE. AS THE HANDPIECE HAS BEEN IN USE FOR APPROXIMATELY 5 YEARS WITHOUT AN REPAIR THIS IS THE RESULT OF THE NORMAL WEAR AND TEAR PROCESS. 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 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. NOTE: THE HERE AFFECTED HANDPIECE 25LP GETS NOT DISTRIBUTED IN THE USA, BUT SIMILAR PRODUCTS - 25LPA AND 25 LPR.

    Description of Event or Problem · 1

    DURING A STANDARD DENTAL TREATMENT THE HANDPIECE HEATED UP AND CAUSED A BURN ON THE INTRAORAL MUCOSA. THE DENTAL OFFICE IS NOT ABLE TO RECALL THE PATIENT NAME TO PULL FILE FOR DETAILS. THEY JUST REMEMBER THAT THEY APPLIED OZONE TO THE BURN AND THAT IT HEALED WITHOUT ANY COMPLICATIONS. NO FURTHER DATA RELATED TO INCIDENT OR PATIENT ARE SUPPLIED, HENCE THE DATE OF EVENT IS BEST ESTIMATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528873 GENTLEPOWER LUX CONTRA ANGLE 25LP DENTAL CONTRA ANGLE HANDPIECE EKX KAVO DENTAL GMBH 25 LP

    Patients

    Seq Age Sex Outcome Treatment
    1