BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 10633196 · Received October 6, 2020

    Report

    Report Number
    9611253-2020-00037
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 2, 2020
    Report Date
    February 17, 2021
    Manufacturer
    NAKANISHI INC.
    Product Code
    DZI
    PMA / PMN Number
    K073678
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021, NAKANISHI RECEIVED INFORMATION ABOUT THE PATIENT FROM THE DOCTOR, BUT THE DOCTOR REFUSED TO DISCLOSE THE PATIENT'S WEIGHT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6), BUT SIMILAR PRODUCTS ARE MARKETED IN THE U.S. UNDER K073678. NAKANISHI IS TRYING TO OBTAIN INFORMATION ABOUT THE PATIENT FROM THE OEM. UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM THE OEM, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [REPORT NO. (B)(4)]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT VS3-LED-HPSC DEVICE [SERIAL NO. (B)(4)]. 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. NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND OBSERVED BREAKAGE OF THE TIP OF THE HANDPIECE. NAKANISHI THEN CONNECTED THE HANDPIECE TO THE COMPANY-OWNED UNIT TO OBSERVE WHETHER OR NOT THE LED IN THE DEVICE WORKS. THE LIGHTING FAILURE OF THE LED WAS CONFIRMED IN THE INSPECTION. ADDITIONALLY, NAKANISHI PERFORMED AN ANALYSIS USING AN X-RAY AND OBSERVED THAT THE GLASS ROD WAS CHIPPED AND CRACKED. NAKANISHI DISASSEMBLED THE DEVICE TO CHECK THE INTERNAL STATE. NAKANISHI CONFIRMED THAT THE GLASS ROD WAS BROKEN. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NAKANISHI COULD NOT CLEARLY IDENTIFY THE CAUSE OF THE REPORTED UNDESIRABLE MATERIALS LEFT IN THE PATIENT'S BODY, HOWEVER, BASED ON THE FINDINGS IN THE VISUAL INSPECTION, NAKANISHI CONSIDERS THE POSSIBILITY THAT THE EVENT WAS CAUSED BY STRESS DUE TO EXTERNAL IMPACT SUCH AS DROPPING THE DEVICE, LEADING TO THE BREAKAGE OF THE GLASS ROD. MISUSE BY THE USER LEADS TO THE EXTERNAL IMPACT, WHICH CONTRIBUTES THE BROKEN INTERNAL PART. IN ORDER TO PREVENT A RECURRENCE OF THE REPORTED EVENT, NAKANISHI TOOK THE FOLLOWING ACTIONS: NAKANISHI REVIEWED THE OPERATION MANUAL, AND RECONFIRMED THE CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. NAKANISHI WILL REPORT THE ABOVE EVALUATION RESULTS TO THE OEM, AND DIRECT THE OEM TO REMIND THE USER OF THE IMPORTANCE OF USING THE DEVICE AS INSTRUCTED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON SEPTEMBER 8, 2020, NAKANISHI RECEIVED A PHONE CALL FROM AN OEM ABOUT A PROBLEM WITH AN NSK HANDPIECE. THE INFORMATION NAKANISHI OBTAINED FROM THE COMMUNICATION IS AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2020. A DOCTOR OBSERVED FOREIGN MATERIALS ON A PATIENT'S X-RAY THE DOCTOR TOOK AFTER PERFORMING A DENTAL SURGERY ON THE PATIENT USING THE VS3-LED-HPSC HANDPIECE (SERIAL NO. (B)(4)). THE DOCTOR PERFORMED ANOTHER SURGERY TO REMOVE THE FOREIGN MATERIALS ON THE SAME DAY. THE FOREIGN MATERIALS TAKEN OUT FROM THE PATIENT WERE ABOUT THE SAME SIZE AS THE BROKEN PART OF THE VS3-LED-HPSC HANDPIECE USED IN THE FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102703 NSK DRILL, BONE, POWERED DZI NAKANISHI INC. VS3-LED-HPSC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other