BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 5426874 · Received February 10, 2016

    Report

    Report Number
    9611253-2016-00006
    Event Type
    Injury
    Date Received
    February 10, 2016
    Date of Event
    December 14, 2015
    Report Date
    July 10, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    PMA / PMN Number
    K970953
    Removal / Correction Number
    9611253-060818-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT FROM A DISTRIBUTOR OF THE DEVICE INVOLVED IN THE MDR EVENT, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [C160126-07-1]. METHODOLOGY USED : NAKANISHI EXAMINED THE DEVICE HISTORY RECORD INCLUDING REPAIR RECORDS FOR THE SUBJECT SGS-E2S DEVICE [SERIAL NUMBER (B)(4).]. THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. NAKANISHI THEN ROTATED THE HANDPIECE AND OBSERVED THAT THE HANDPIECE DID NOT ROTATE AT ALL. NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS. NAKANISHI OBSERVED AS FOLLOWS : BEARING (1) : ABRASION, BEARING (2) : BREAKAGE, ABRASION MARK IN THE INNER RACE OF THE BEARING, BEARING (3) : DIRT/DISCOLORATION, GEAR : DISCOLORATION, NAKANISHI TOOK PHOTOGRAPHS OF ALL THE DISASSEMBLED PARTS AND KEPT THEM IN A FILE. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS : NAKANISHI IDENTIFIED THAT THE CAUSE OF OVERHEATING OF THE RETURNED DEVICE WAS DUE TO THE BEARINGS BROKEN BY DIRT INGRESS. A LACK OF MAINTENANCE CAUSES THE ABOVE SITUATION, WHICH WILL CONTRIBUTE TO THE HANDPIECE OVERHEATING. AFTER REPLACING THE BROKEN BEARINGS WITH THE NEW BEARINGS, NAKANISHI CONFIRMED THAT THE HANDPIECE ROTATED NORMALLY AND DID NOT OVERHEATED. NAKANISHI TOOK THE FOLLOWING ACTIONS IN ORDER TO PREVENT A RECURRENCE OF THE HANDPIECE OVERHEATING. NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DENTIST AND REMINDED THE DENTIST OF THE IMPORTANCE OF MAINTENANCE AND CHECKING OF THE HANDPIECE PRIOR TO USE TO PREVENT OVERHEATING AS INSTRUCTED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON (B)(6) 2016, NAKANISHI RECEIVED A PHONE CALL FROM A DISTRIBUTOR ABOUT AN NSK DENTAL PRODUCT. DETAILS ARE AS FOLLOWS. ON (B)(6) 2016, A DENTIST WAS CUTTING A BONE OF A PATIENT TO EXTRACT A WISDOM TOOTH USING NSK SURGICAL HANDPIECE, SGS-E2S. THE PATIENT WAS UNDER GENERAL ANESTHESIA. A BURN INJURY (2.0 CENTIMETERS BY 0.5 CENTIMETERS) WAS OBSERVED ON THE PATIENT'S ORAL MUCOSA MEMBRANE. THE DENTIST DID NOT FEEL HEAT AT THE HANDPIECE GRIP WHERE HE WAS HOLDING, BUT FELT HEAT AT THE TIP OF THE HANDPIECE. THE DENTIST DECIDED TO GIVE THE PATIENT FOLLOW-UP OBSERVATIONS INSTEAD OF MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84768 NSK HANDPIECE, ROTARY BONE CUTTING KMW NAKANISHI INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other