BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 10732463 · Received October 26, 2020

    Report

    Report Number
    9611253-2020-00040
    Event Type
    Injury
    Date Received
    October 26, 2020
    Date of Event
    September 4, 2020
    Report Date
    January 14, 2021
    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
    IN, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2020, NAM UPDATED NAKANISHI ABOUT THE EVENT. DESPITE THE FOLLOWING ATTEMPTS, NAM RECEIVED NO RESPONSE FROM THE DENTIST. ON (B)(6) 2020, NAM MADE A PHONE CALL TO THE DENTAL OFFICE FOR DETAILED INFORMATION ABOUT THE EVENT. NAM LEFT A VOICEMAIL MESSAGE REQUESTING THE DENTAL OFFICE TO CONTACT NAM. ON (B)(6) 2020, NAM CALLED THE OFFICE AGAIN AND LEFT ANOTHER MESSAGE ON THE VOICEMAIL. ON (B)(6) 2020, NAM SENT AN E-MAIL TO THE DENTIST REQUESTING THE DETAILS. ON (B)(6) 2020, NAM SENT ANOTHER E-MAIL TO THE DENTIST.

    Additional Manufacturer Narrative · 1

    THE DISTRIBUTOR IS ATTEMPTING TO OBTAIN FURTHER INFORMATION ON THE EVENT, INCLUDING 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 (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 SGS-E2S 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. NAKANISHI SET A TEST BUR IN THE HANDPIECE, CONNECTED THE HANDPIECE TO THE MOTOR, AND TRIED TO ROTATE THE MOTOR. HOWEVER, THE HANDPIECE WAS LOCKED AND THE MOTOR DID NOT ROTATE AT ALL. 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: NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INTERNAL PARTS. NAKANISHI OBSERVED THE FOLLOWING PHENOMENA: THE GEAR SHAFT DID NOT ROTATE AT ALL. THERE WAS DEBRIS ON THE BEARING. THE INTERNAL PARTS WERE CORRODED. NAKANISHI TOOK PHOTOGRAPHS OF ALL OF THE DISASSEMBLED PARTS AND KEPT THEM IN THE INVESTIGATION REPORT # (B)(4). CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS: NAKANISHI COULD NOT REPLICATE THE TEMPERATURE INCREASE FROM THE EVENT, BUT BASED ON THE FINDINGS IN THE VISUAL INSPECTION, AS WELL AS MANY YEARS OF EXPERIENCE, NAKANISHI IDENTIFIED THE CAUSE OF THE HANDPIECE OVERHEATING WAS ABNORMAL RESISTANCE DURING ROTATION DUE TO THE SOILED BEARING CAUSED BY INGRESS OF FOREIGN MATERIALS INTO THE HANDPIECE. A LACK OF MAINTENANCE CAUSES THE ACCUMULATION OF DEBRIS ON THE INSIDE PARTS, WHICH CAUSES DEBRIS INGRESS INTO THE BEARING DURING ROTATION. THIS CONTRIBUTES TO THE HANDPIECE OVERHEATING. IN ORDER TO PREVENT A RECURRENCE OF THE HANDPIECE OVERHEATING, NAKANISHI TOOK THE FOLLOWING ACTIONS: NAKANISHI REVIEWED THE OPERATION MANUAL, RECONFIRMED CLARITY, AND UNDERSTANDABILITY OF THE INSTRUCTIONS. NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO NSK AMERICA AND DIRECTED NSK AMERICA TO REMIND THE USER OF THE IMPORTANCE OF MAINTENANCE, AS INSTRUCTED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON OCTOBER 3, 2020, NAKANISHI BECAME AWARE OF A HANDPIECE OVERHEATING THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2020. A DENTIST WAS PERFORMING A DENTAL PROCEDURE ON A PATIENT USING THE SGS-E2S HANDPIECE (SERIAL NO.: (B)(4)). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED AND BURNED THE PATIENT'S INNER CHEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197554 NSK HANDPIECE, ROTARY BONE CUTTING KMW NAKANISHI INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other