BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 17359025 · Received July 20, 2023

    Report

    Report Number
    9611253-2023-00042
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 7, 2023
    Report Date
    September 1, 2023
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K182999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM THE DISTRIBUTOR, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [REPORT NO. C230630-02]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT Z95L DEVICE [DBKZ0682]. 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 A VISUAL INSPECTION OF THE RETURNED DEVICE AND OBSERVED THAT THE HEADCAP REMAINED DEPRESSED IN THE HANDPIECE. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) OF THE ASSOCIATED DEVICE COMPONENTS WAS CONDUCTED AS FOLLOWS: A) NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INTERNAL PARTS. NAKANISHI OBSERVED THE FOLLOWING: - THE HEADCAP WAS DEFORMED. - THE REAR SIDE OF THE CARTRIDGE PARTS WERE ABRADED. B) NAKANISHI TOOK PHOTOGRAPHS OF ALL THE DISASSEMBLED PARTS AND KEPT THEM IN THE INVESTIGATION REPORT NO. C230630-02. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: A) NAKANISHI IDENTIFIED FROM THE FINDINGS IN THE VISUAL INSPECTION, AS WELL AS MANY YEARS OF EXPERIENCE THAT THE CAUSE OF THE BUR SEPARATION FROM THE RETURNED HANDPIECE WAS THE OPENED CHUCK, WHICH WAS CAUSED BY THE HEADCAP REMAINING DEPRESSED DURING ROTATION (SLIDING FAILURE) B) NAKANISHI ALSO CONSIDERED THE HEADCAP WAS DEFORMED DUE TO IMPACT OR DROP AS A CAUSE OF SLIDING FAILURE. C) MISUSE BY THE USER LED TO THE ABOVE ISSUE, WHICH CONTRIBUTED TO THE REPORTED EVENT. D) IN ORDER TO PREVENT A RECURRENCE OF THE BUR SEPARATION , NAKANISHI TOOK THE FOLLOWING ACTIONS: D.1) NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED THE CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. D.2) NAKANISHI WILL REPORT THE ABOVE EVALUATION RESULTS TO THE DISTRIBUTOR AND DIRECTED THE DISTRIBUTOR TO REMIND THE USER OF THE IMPORTANCE OF USING THE DEVICE AS INSTRUCTED IN THE OPERATION MANUAL.

    Additional Manufacturer Narrative · 0

    THE SAME ADVERSE EVENT IN THIS REPORT HAS BEEN REPORTED TO THE FDA SEPARATELY BY THE DISTRIBUTOR, NSK AMERICA CORPORATION, UNDER REPORT NUMBER 1422375-2023-00019.

    Description of Event or Problem · 0

    ON JUNE 30, 2023, NAKANISHI BECAME AWARE OF A MALFUNCTION OF A NSK HANDPIECE THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2023. A DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE Z95L HANDPIECE (SERIAL NO. (B)(6)). DURING THE PROCEDURE, THE BUR WAS RELEASED FROM THE HANDPIECE AND LANDED AT THE BACK OF THE PATIENT'S THROAT. THE PATIENT COUGHED THE BUR UP AND THE BUR WAS RECOVERED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766043 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. Z95L

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other