BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI X C1 5L

    MDR report key: 4640919 · Received March 24, 2015

    Report

    Report Number
    9611253-2015-00048
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Report Date
    March 17, 2015
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    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. NAKANISHI MEASURED THE TEMPERATURE OF THE HANDPIECE HEAD WHICH ROSE SUDDENLY AFTER BEGINNING THE MEASUREMENT TEST. IN FACT. THE RISE WAS SO SUDDEN MORE THAN 80 DEGREES AT THE HEAD WHICH MIGHT HAVE CAUSED-THE PATIENT'S INJURY. TO PRESERVE HANDPIECE'S CONDITION, WE STOPPED THE MEASUREMENT AFTER 15 SECONDS. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND TILE ASSOCIATED DEVICE COMPONENTS INVOLVED. NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS. NAKANISHI OBSERVED WORN POWDER OF BALL BEARING RETAINER BUILDUP INSIDE THE HEAD CAP AND THE CARTRIDGE (HEAD CAP SIDE). NAKANISHI BELIEVE THAT OVERHEATING WAS CAUSED BY THE WEAR OF BEARING RETAINER. TILE BEARING RETAINER INCREASED THE REAR BEARING LOAD AND CAUSED EXCESS HEAT GENERATION. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. NAKANISHI IDENTIFIED THAT THE CAUSE OF OVERHEATING OF THE RETURNED DEVICE WAS DUE TO DAMAGE TO THE BEARING RETAINER. THE DAMAGE OBSERVED CAUSED ABNORMAL ROTATIONAL RESISTANCE, WHICH WOULD RESULT IN THE HANDPIECE OVERHEATING.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM DISTRIBUTOR TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK. EVENT SUMMARY : ON JUNE 21, 2013, NSK RECEIVED AN ELECTRIC DENTAL HANDPIECE MODEL TI-X C1:5L, SERIAL NUMBER (B)(4) FOR REPAIR FROM A DISTRIBUTOR REPAIR FACILITY. ON THE DISTRIBUTOR'S DOCUMENTATION WAS STATEMENT: PA!LENT BURNED WITH THIS HANDPIECE. NSK DID NOT GET INFORMATION WHEN THE EVENT OCCURRED. THE PATIENT'S CHEEK AND BUCCAL MUCOSA WERE BURNED. 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 JUNE 21, 2013. AND EVALUATION WAS FINISHED ON JULY 2, 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198067 TI X C1 5L HANDPIECE, CONTRA AND RIGHT ANGLE ATTACHEMENT, DENTAL EGS NAKANISHI, INC. (NSK) TI X C1 5L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other