BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK X85L

    MDR report key: 4690556 · Received April 8, 2015

    Report

    Report Number
    9611253-2015-00034
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Report Date
    March 30, 2015
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REVIEW: THERE WAS NO REPAIR HISTORY ON FILE FOR THIS HANDPIECE. INVESTIGATION: THE HANDPIECE WAS FORWARDED TO THE MANUFACTURER FOR TESTING AND ANALYSIS ON JANUARY 13, 2014. AND THE EVALUATION WAS FINISHED ON JANUARY 21, 2014. UPON RECEIPT FROM THE DENTIST OF THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE THAT INCLUDED AN ATTEMPT TO MEASURE THE TEMPERATURE OF THE OPERATING DEVICE. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED : NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND PERFORMED A SIMPLE MOVEMENT TEST. THERE WERE NO VISIBLE ABNORMALITIES, SUCH AS CRACKS OR DEBRIS, ON THE OUTSIDE OF THE HANDPIECE. NAKANISHI THEN SET A TEST BUR IN THE HANDPIECE AND ROTATED IT BY HAND. NAKANISHI OBSERVED THAT THE BUR ROTATED SMOOTHLY. DURING THE MEASUREMENT TEST, NAKANISHI OBSERVED THAT THE TEMPERATURE OF THE HANDPIECE HEAD DID NOT GET HIGH ENOUGH TO CAUSE A BURN. IDENTIFICATION OF THE SPECIFIC FAILURE MODE{S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENTS INVOLVED. NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS. NAKANISHI DID NOT OBSERVE ANY BUILD-UP OF SHAVINGS FROM THE BALL BEARING IN THE RETAINER INSIDE THE HEAD CAP AND THE CARTRIDGE (HEAD CAP SIDE). THE AMOUNT OF OIL OBSERVED INSIDE THE HANDPIECE INDICATED THAT THE DEVICE WAS NOT ADEQUATELY CLEANED. NAKANISHI BELIEVES THAT OVERHEATING WAS DUE TO THE LACK OF OIL INSIDE OF CARTRIDGE. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. NAKANISHI IDENTIFIED THAT THE CAUSE OF OVERHEATING OF THE RETURNED DEVICE WAS LACK OF MAINTENANCE AND THIS WOULD RESULT IN THE HANDPIECE OVERHEATING.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM A DISTRIBUTOR TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK. EVENT SUMMARY: ON JANUARY 13, 2014, NSK RECEIVED AN ELECTRIC DENTAL HANDPIECE MODEL X85L, SERIAL NUMBER (B)(4) FOR REPAIR FROM A DISTRIBUTOR REPAIR FACILITY. ON THE DISTRIBUTOR'S DOCUMENTATION WAS STATEMENT: PATIENT BURNED WITH THIS HANDPIECE. NSK DID NOT GET INFORMATION REGARDING WHEN THE EVENT OCCURRED OR DETAILS ABOUT THE BURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230362 NSK X85L HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT,DENTAL, PRODUCT CODE: EGS EGS NAKANISHI, INC. (NSK) X85L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other