BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL CONTRA ANGLE HANDPIECE WS-92 E/3

    MDR report key: 2727225 · Received July 31, 2012

    Report

    Report Number
    9681479-2012-00002
    Event Type
    Injury
    Date Received
    July 31, 2012
    Date of Event
    June 21, 2012
    Report Date
    July 4, 2012
    Manufacturer
    W&H DENTALWERK BURMOOS GMBH
    Product Code
    EGS
    PMA / PMN Number
    K011061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON HAVING REC'D THE HANDPIECE WS-92 E/3 (SN: (B)(4)) FROM OUR PARTNER IN (B)(6), WE PERFORMED DETAILED EXAMINATION IN THIS MATTER: THE FREE ROTATION OF THE GEARING ELEMENTS WERE HAMPERED. DURING TEST RUN THE HANDPIECE HEAVILY VIBRATED, WAS EXTREMELY LOUD AND WARMED UP RAPIDLY DUE TO A DENT IN THE GRIPPING SHEATH (HANDPIECE POSSIBLY DROPPED?). IT WAS DIFFICULT TO DISASSEMBLE THE HANDPIECE. ALL INNER COMPONENTS (GEARING ELEMENTS, BEARINGS, ETC.) AND INNER SURFACE WERE HEAVILY SOILED, WHICH IS A SIGN FOR LACK OF MAINTENANCE. ONE OF TWO MIDDLE GEAR BALL BEARINGS ASSEMBLIES WERE BROKEN - ALL OTHER BEARINGS DID NOT WORK PROPERLY BECAUSE OF BEING SOILED. SUMMING UP, THE ANALYSIS CONFIRMED THAT THE HIGH FRICTION OF THE GEARING ELEMENTS AND FRACTURE OF THE BALL BEARING ASSEMBLY CAUSED RAPID HEATING OF THE HANDPIECE. ACCORDING TO THE IFU THE HANDPIECE HAS TO BE CHECKED FOR DAMAGE AND LOOSE PARTS (EXCESSIVE VIBRATION) PRIOR TO USE (SEE P. 6) AND HAS TO BE CLEANED AND MAINTAINED IMMEDIATELY AFTER EVERY TREATMENT (P. 24). FOR PROPER MAINTENANCE AND CLEANING, DISASSEMBLY IS RECOMMENDED (P. 29). W AND H INSTRUCTS FURTHERMORE TO LUBRICATE AFTER EVERY INTERNAL CLEANING AND BEFORE EACH STERILIZATION (P. 41) AND ADDITIONALLY TO PERFORM A TEST RUN AFTER EACH LUBRICATION CYCLE (P. 44) WHICH WOULD HELP TO DETECT VIBRATIONS, UNUSUAL NOISE, OVERHEATING, ETC. W AND H CONCLUDES THIS INCIDENT COULD HAVE BEEN AVOIDED IF THE HANDPIECE WOULD HAVE BEEN MAINTAINED IN ACCORDANCE WITH THE IFU. THE USER WILL BE RE-INSTRUCTED TO MAINTAIN THE PRODUCTS CORRESPONDING TO THE INSTRUCTION FOR USE (IFU).

    Description of Event or Problem · 1

    DURING A DENTAL TREATMENT ON A PT IN A CLINIC IN FRANCE THE HANDPIECE HEATED UP. THE HANDPIECE WAS IN DIRECT CONTACT WITH THE RIGHT SIDE OF THE LOWER LIP. THIS LED TO A BURN OF THE RED AREA OF THE LIP AND THE SURROUNDING SKIN. THE INITIAL-TREATMENT OF THE PT WAS DONE DIRECTLY IN THE CLINIC. A SKIN TRANSPLANTATION FOR THE BURNED AREA WAS DONE AND THE PT HAD TO REMAIN IN THE CLINIC FOR THREE DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL CONTRA ANGLE HANDPIECE WS-92 E/3 76-EGS EGS W&H DENTALWERK BURMOOS GMBH 10209201

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention MICRO MOTOR| DENTAL BURR