BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 7463543 · Received April 26, 2018

    Report

    Report Number
    9611253-2018-00020
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    April 12, 2018
    Report Date
    July 17, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NAKANISHI TOOK THE FOLLOWING ACTIONS TO OBTAIN THE PATIENT INFORMATION, HOWEVER NO INFORMATION WAS PROVIDED. ON APRIL 25, 2018, NAKANISHI CONTACTED THE DISTRIBUTOR (NUK) VIA NSK EUROPE (NEU) FOR THE INFORMATION AND RECEIVED AN E-MAIL FROM NUK STATING THAT NUK FORWARDED THE "ADDITIONAL INFORMATION FORM" (INFORMATION REQUEST FORM) TO THE DENTIST. ON JUNE 22, 2018, NAKANISHI SENT AN E-MAIL TO NUK TO ASK WHETHER OR NOT THE DENTIST HAD PROVIDED THE INFORMATION. NO RESPONSE WAS RECEIVED. SEVERAL DAYS LATER (EXACT DATE UNKNOWN), NAKANISHI MADE A PHONE CALL TO NUK TO HEAR THE PROGRESS. NO ONE WAS AVAILABLE IN THE OFFICE.

    Additional Manufacturer Narrative · 0

    NAKANISHI IS STILL TRYING TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT, INCLUDING INFORMATION ABOUT THE PATIENT. UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM A DISTRIBUTOR, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [C180425-01]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT NANO95LS DEVICE [SERIAL NUMBER: (B)(4)]. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. THERE WERE ALSO NO REPAIR HISTORY RECORDS SINCE THE DEVICE WAS SHIPPED. B) NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. OTHER THAN THE HEADCAP MISSING FROM THE HANDPIECE WHEN THE DEVICE WAS RETURNED, THERE WERE NO VISIBLE ABNORMALITIES ON THE OUTSIDE OF THE HANDPIECE, SUCH AS CRACKS, DENTS, OR DEFORMATION. C) NAKANISHI OBSERVED WHETHER OR NOT A HEADCAP ATTACHED TO THE RETURNED HANDPIECE WOULD LOOSEN BY ROTATING WITHOUT LOAD AND THEN CUTTING MELAMINE AND COPPER PLATES AT THE MAXIMUM SPEED (200,000MIN-1). A NEW HEADCAP WAS USED FOR THIS TESTING BECAUSE THE HEADCAP INVOLVED IN THE EVENT WAS NOT RETURNED. THERE WAS NO HEADCAP LOOSENING OBSERVED IN THE EVALUATION. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: 1) ALTHOUGH NAKANISHI COULD NOT REPLICATE THE REPORTED EVENT, NAKANISHI CONSIDERS THE POSSIBILITY, FROM SIMILAR PHENOMENON NSK HAS EXPERIENCE IN THE PAST, THAT THE COMBINATION OF A STRONG IMPACT ON THE DEVICE WITH CUTTING VIBRATION COULD RESULT IN THE REPORTED HEADCAP LOOSENING/COMING OFF. 2) FAILURE TO CHECK THE HEADCAP TIGHTNESS BEFORE EACH USE AS INSTRUCTED IN THE OPERATION MANUAL CONTRIBUTES TO THE HEADCAP LOOSENING/COMING OFF. 3) IN ORDER TO PREVENT A RECURRENCE OF THE HEADCAP LOOSENING/COMING OFF, NAKANISHI TOOK THE FOLLOWING ACTIONS: 3.1) NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. 3.2) NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO NSK EUROPE AND DIRECTED NSK EUROPE TO REMIND THE USER OF THE IMPORTANCE OF CHECKING THE HANDPIECE BEFORE USE AS INSTRUCTED IN THE OPERATION MANUAL.

    Additional Manufacturer Narrative · 1

    (B)(6) IS NOW TRYING TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT INCLUDING THE PATIENT. THIS EVENT OCCURRED IN THE (B)(6), BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K972569.

    Description of Event or Problem · 1

    ON (B)(6) 2018, (B)(6) RECEIVED AN E-MAIL FROM A (B)(4) ABOUT A HEADCAP COMING OFF. DETAILS ARE AS FOLLOWS. THE DATE WHEN THE EVENT OCCURRED IS UNKNOWN. A DENTIST WAS PERFORMING A DENTAL PROCEDURE USING THE NANO95LS HANDPIECE (SERIAL NO.: (B)(4)). DURING THE PROCEDURE, THE HEADCAP CAME OUT OF THE HANDPIECE AND THE PATIENT SWALLOWED THE HEADCAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308019 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. NANO95LS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other