BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 20233393 · Received September 16, 2024

    Report

    Report Number
    9611253-2024-00046
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 17, 2024
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    PMA / PMN Number
    K171155
    Removal / Correction Number
    9611253-060818-001-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DENTIST REFUSED TO PROVIDE ANY INFORMATION ABOUT THE PATIENT. UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM THE DISTRIBUTOR, NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE [REPORT NO. C240821-01]. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW. METHODOLOGY USED: A) NAKANISHI EXAMINED THE DEVICE HISTORY RECORD AND THE REPAIR HISTORY FOR THE SUBJECT SGS-E2S 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) THE HANDPIECE WAS ALREADY DISASSEMBLED WHEN THE DEVICE WAS RETURNED. THEREFORE, NAKANISHI WAS NOT ABLE TO CONDUCT TEMPERATURE TESTING OF THE DEVICE. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) OF THE ASSOCIATED DEVICE COMPONENTS WAS CONDUCTED AS FOLLOWS: A) NAKANISHI PERFORMED A VISUAL INSPECTION OF THE DISASSEMBLED HANDPIECE. NAKANISHI OBSERVED THAT THE BEARING WAS SOILED, DISCOLORED, AND BROKEN. B) NAKANISHI TOOK PHOTOGRAPHS OF ALL THE DISASSEMBLED PARTS AND KEPT THEM IN THE INVESTIGATION REPORT NO. C240821-01. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: A) NAKANISHI COULD NOT REPLICATE THE TEMPERATURE INCREASE FROM THE EVENT, BUT BASED ON THE FINDINGS IN THE VISUAL INSPECTION, NAKANISHI IDENTIFIED THAT THE CAUSE OF THE HANDPIECE OVERHEATING WAS ABNORMAL RESISTANCE DURING ROTATION DUE TO THE BROKEN BEARING. B) NAKANISHI ALSO CONSIDERS THE POSSIBILITY FROM MANY YEARS OF EXPERIENCE THAT THE CAUSE OF THE BROKEN BEARING WAS THE INGRESS OF UNDESIRABLE MATERIALS INTO THE BEARING, LEADING TO ABRASION. C) A LACK OF MAINTENANCE CAUSED THE ACCUMULATION OF DEBRIS ON THE INTERNAL PARTS, WHICH CONTRIBUTED TO THE HANDPIECE OVERHEATING. 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 DISTRIBUTOR AND DIRECTED THE DISTRIBUTOR TO REMIND THE USER OF THE IMPORTANCE OF MAINTENANCE, AS INSTRUCTED IN THE OPERATION MANUAL.

    Description of Event or Problem · 0

    ON AUGUST 21, 2024, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK OCEANIA). DETAILS ARE AS FOLLOWS: - THE EVENT OCCURRED ON AUGUST 21, 2024. - THE DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE SGS-E2S HANDPIECE (SERIAL NO. (B)(6) ). - DURING THE PROCEDURE, THE HANDPIECE OVERHEATED, AND THE PATIENT RECEIVED A BURN TO THEIR LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531271 NSK HANDPIECE, ROTARY BONE CUTTING KMW NAKANISHI INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other