BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 22516408 · Received July 15, 2025

    Report

    Report Number
    9611253-2025-00035
    Event Type
    Injury
    Date Received
    July 15, 2025
    Report Date
    August 20, 2025
    Manufacturer
    NAKANISHI INC.
    Product Code
    DZI
    UDI-DI
    04560264537767
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON JULY 30, 2025, NAKANISHI RECEIVED AN EMAIL, STATING THAT THE DENTIST REFUSED TO PROVIDE INFORMATION ABOUT THE DATE OF INCIDENT AND THE PATIENT, FROM THE DISTRIBUTOR.

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED IN JAPAN, BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K073678. UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE, WHICH INCLUDED MEASURING THE OPERATING TEMPERATURE OF THE DEVICE [REPORT NO. C250620-04]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT VS3-LED-HPSC DEVICE [SERIAL NO. (B)(6)]. THERE WERE NO PROBLEMS OBSERVED DURING MANUFACTURING OR TESTING NOTED IN THE DHR. THERE WERE ALSO NO REPAIR HISTORY RECORDS SINCE THE DEVICE WAS SHIPPED. B) NAKANISHI CONDUCTED TEMPERATURE TESTING OF THE RETURNED DEVICE IN THE FOLLOWING MANNER: B.1) TEMPERATURE SENSORS WERE ATTACHED TO THE EXTERIOR OF THE DEVICE AT VARIOUS TEST POINTS. THIS INCLUDED THE POINT MOST PROXIMAL TO THE PATIENT (TESTING POINT (1)) AND POINTS FURTHER TOWARD THE DISTAL END OF THE DEVICE (TESTING POINTS (2) AND (3)). THE TEST SETUP WAS PREPARED TO TAKE TEMPERATURE MEASUREMENTS AT ALL POINTS SIMULTANEOUSLY, INCLUDING A REFERENCE MEASUREMENT AT AMBIENT ROOM TEMPERATURE. B.2) NAKANISHI ATTACHED A THERMOCOUPLE (SENSOR TO MEASURE TEMPERATURE) TO EACH OF THE TESTING POINTS. NAKANISHI VIBRATED THE DEVICE WITH THE SG1 TIP IN THE SPECIFIED MODE AND POWER RANGE WITH WATER SPRAY AND MEASURED THE EXOTHERMIC RESPONSE. B.3) NAKANISHI MEASURED THE TEMPERATURE RISE OF THE RETURNED HANDPIECE. NAKANISHI DID NOT OBSERVE RISES IN TEMPERATURE AT THE TEST POINTS AS SHOWN BELOW. THE TEMPERATURE MEASURED 30 MINUTES INTO THE TEST WERE AS FOLLOWS: TEST POINT (1): 24.4 DEGREES C, TEST POINT (2): 30.4 DEGREES C, TEST POINT (3): 25.4 DEGREES C. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: A) NAKANISHI DETERMINED, BASED ON THE HEARING FROM THE DENTIST, THAT THE CAUSE OF THE HANDPIECE OVERHEATING WAS USE OF THE HANDPIECE WITHOUT WATER SPRAY AND BEYOND THE SPECIFIED POWER RANGE. B) MISUSE BY THE USER LED TO THE HANDPIECE OVERHEATING, WHICH CONTRIBUTED TO THE REPORTED EVENT. D) IN ORDER TO PREVENT A RECURRENCE OF THE HANDPIECE OVERHEATING, NAKANISHI TOOK THE FOLLOWING ACTIONS: D.1) NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED THE CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. D.2) NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DENTIST AND REMINDED THE DENTIST OF THE IMPORTANCE OF USING THE DEVICE AS INSTRUCTED IN THE OPERATION MANUAL AND CHECKING OF THE HANDPIECE PRIOR TO USE TO PREVENT OVERHEATING. FURTHER INFORMATION OR STATUS ABOUT THE EVENT INCLUDING THE DATE OF INCIDENT AND THE PATIENT HAS NOT BEEN PROVIDED AT THIS TIME OF THIS REPORT. NAKANISHI IS STILL TRYING TO OBTAIN THE INFORMATION ABOUT THE EVENT AND A FOLLOW-UP REPORT WILL BE MADE IF FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON JUNE 19, 2025, NAKANISHI RECEIVED A PHONE CALL FROM A DEALER ABOUT AN NSK HANDPIECE OVERHEATING. UPON RECEIPT OF THE INFORMATION, NAKANISHI VISITED THE HOSPITAL FOR FURTHER INFORMATION ABOUT THE EVENT INCLUDING INFORMATION ABOUT THE PATIENT. THE DETAILS NAKANISHI OBTAINED ARE AS FOLLOWS. - THE DENTIST WAS PERFORMING A MANDIBULAR BONE CUTTING PROCEDURE ON A PATIENT USING THE VS3-LED-HPSC HANDPIECE (B)(6) TOGETHER WITH SG1 SURGERY TIP. - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A BURN INJURY TO THEIR LOWER LIP. - THE DENTIST WAS USING THE HANDPIECE WITHOUT WATER SPRAY, EXCEEDING THE POWER SETTING SPECIFIED FOR EACH TYPE OF TIP AT THIS TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168448 NSK DRILL, BONE, POWERED DZI NAKANISHI INC. VS3-LED-HPSC 04560264537767

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other