BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK X95L

    MDR report key: 4548493 · Received February 20, 2015

    Report

    Report Number
    9611253-2015-00014
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    December 3, 2014
    Report Date
    February 10, 2015
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE THAT INCLUDED MEASUREMENT OF THE TEMPERATURE OF THE OPERATING (B)(4). THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW: METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORD FOR THE SUBJECT X95L DEVICE (SERIAL NUMBER (B)(4)). THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND PERFORMED A SIMPLE MOVEMENT TEST. THERE WERE NO VISIBLE ABNORMALITIES, SUCH AS CRACKS OR DENTS, ON THE OUTSIDE OF THE HANDPIECE. NAKANISHI THEN SET A TEST BUR IN THE HANDPIECE AND ROTATE IT BY HAND TO SEE BEARING CONDITION. NAKANISHI OBSERVED THAT THE BUR ROTATED SMOOTHLY. THE DEVICE WAS CONFIGURED FOR TEMPERATURE TESTING IN THE EXACT STATE IN WHICH IT WAS RETURNED. SPECIFICALLY, NO LUBRICATION OR CLEANING WAS PERFORMED ON THE RETURNED DEVICE BEFORE THIS FIRST TEST IN ORDER TO CHARACTERIZE THE DEVICE UNDER CONDITIONS THAT WOULD DUPLICATE THE USE SITUATION AT THE TIME OF EVENT. TEMPERATURE SENSORS WERE FIRST ATTACHED TO THE EXTERIOR OF THE DEVICE AT VARIOUS TEST POINTS. THE TEST SETUP WAS PREPARED TO TAKE TEMPERATURE MEASUREMENTS AT ALL PONTS SIMULTANEOUSLY, INCLUDING A REFERENCE MEASUREMENT AT AMBIENT ROOM TEMPERATURE. NAKANISHI ATTACHED A THERMOCOUPLE (SENSOR TO MEASURE A TEMPERATURE) TO EACH OF THE TESTING POINTS A, B, C, AND D FOR THE HANDPIECE WITH WATER SPRAY AND MEASURED THE EXOTHERMIC SITUATION. NAKANISHI MEASURED THE TEMPERATURE RISE OF THE RETURNED HANDPIECE SET AT 200,000 RPM (MOTOR REVOLUTION 40,000 RPM). NAKANISHI CONFIRMED THE TEMPERATURE AT EACH OF THE TEST POINTS AS FOLLOWS AFTER THE BEGINNING OF THE MEASUREMENT: 33.2 DEGREE C , 35.4 DEGREE C, 31.3 DEGREE C, AND 30.2 DEGREE C. IN THE 5 MINUTES EVALUATION PERIOD, THERE WAS NO SUDDEN TEMPERATURE RISE OBSERVED THAT MAY CAUSE A BURN. IDENTIFICATION OF THE SPECIFIC FAILURE MODE AND/OR MECHANISM AND THE ASSOCIATED DEVICE COMPONENT INVOLVED. NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS. NAKANISHI DID NOT OBSERVE ANY DAMAGE, DIRT, FOREIGN PARTICLES LEADING TO A BURN ON THE INSIDE PARTS. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS. THE NAKANISHI INVESTIGATION COULD NOT REPLICATE THE EVENT/SITUATION REPORTED BY THE COMPLAINT. BASED ON THE ABOVE EVALUATION, NAKANISHI CONCLUDED THAT THERE WERE NO SAFETY ISSUES ON THE HANDPIECE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM DENTIST TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK. EVENT SUMMARY: ON (B)(6) 2015, NSK RECEIVED AN ELECTRIC DENTAL HANDPIECE MODEL X95L, SERIAL NUMBER (B)(4) FOR REPAIR FROM A DISTRIBUTOR REPAIR FACILITY. ON THE DISTRIBUTOR'S DOCUMENTATION WAS STATEMENT: PATIENT BURNED WITH THIS HANDPIECE. WE DO NOT GET ANY DETAIL INFORMATION ABOUT THIS BURN. 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 (B)(6) 2015. AND EVALUATION WAS FINISHED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122057 NSK X95L HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. X95L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other