BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 7372417 · Received March 26, 2018

    Report

    Report Number
    9611253-2018-00013
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    February 26, 2018
    Report Date
    April 12, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    HBC
    PMA / PMN Number
    K132264
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE DISTRIBUTOR, THE DENTIST REFUSED TO PROVIDE INFORMATION OTHER THAN THE PATIENT'S SEX. THIS EVENT OCCURRED IN JAPAN, BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K132264.

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE DEVICE INVOLVED IN THE MDR EVENT FROM A 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 A235S 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) SINCE THE HANDPIECE WAS RETURNED FROM THE DISTRIBUTOR IN PIECES, NAKANISHI WAS NOT ABLE TO CONDUCT TEMPERATURE TESTING OF THE DEVICE. THE FOLLOWING IS THE RESULTS OF THE TEMPERATURE MEASUREMENT THE DISTRIBUTOR PERFORMED AND REPORTED TO NAKANISHI. CONDITIONS: THE HANDPIECE WAS CONNECTED TO THE AIR DRILL SYSTEM PRODUCED BY MINOS CO., LTD. AND ROTATED UNDER THE PRESSURE OF 100PSI. TESTING POINT: THE TIP OF THE ATTACHMENT TEMPERATURE OBSERVED 60 SECONDS AFTER THE START: 88.7 DEGREES C. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) AND/OR MECHANISM(S) AND THE ASSOCIATED DEVICE COMPONENTS INVOLVED: NAKANISHI PERFORMED A VISUAL INSPECTION OF THE DISASSEMBLED HANDPIECE AND OBSERVED THE FOLLOWING PHENOMENA: THE BEARING RETAINER (BALL RETAINING PLASTIC PART) ON THE TIP OF THE ATTACHMENT WAS BROKEN. A PART OF THE ROTATION TRANSMISSION GEAR WAS EXTREMELY ABRADED. 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 IDENTIFIED THAT THE CAUSE OF THE OVERHEATING OF THE RETURNED DEVICE WAS ABNORMAL RESISTANCE DURING ROTATION CAUSED BY THE BROKEN BEARING RETAINER DUE TO DETERIORATION IN NORMAL USE OR THE INGRESS OF UNDESIRABLE MATERIALS INTO THE BEARING. FAILURE TO CHECK THE DEVICE STATE PRIOR TO USE, AND A LACK OF MAINTENANCE COULD CONTRIBUTE TO THE REPORTED EVENT. IN ORDER TO PREVENT A RECURRENCE OF THE HANDPIECE OVERHEATING, NAKANISHI TOOK THE FOLLOWING ACTIONS: NAKANISHI REVIEWED THE OPERATION MANUAL AND RECONFIRMED CLARITY AND UNDERSTANDABILITY OF THE INSTRUCTIONS. NAKANISHI REPORTED THE ABOVE EVALUATION RESULTS TO THE DISTRIBUTOR AND DIRECTED THE DISTRIBUTOR TO REMIND THE USER OF THE IMPORTANCE OF PREUSE CHECK AND OF MAINTENANCE, AS INSTRUCTED IN THE OPERATION MANUAL.

    Description of Event or Problem · 1

    ON (B)(6) 2018, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ABOUT AN NSK HANDPIECE OVERHEATING. UPON RECEIPT OF THE INFORMATION, NAKANISHI SENT AN INFORMATION REQUEST FORM TO THE DISTRIBUTOR AND OBTAINED INFORMATION ABOUT THE EVENT AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2018. A DENTIST WAS EXTRACTING A TOOTH USING THE HANDPIECE, A235S (SERIAL NO. (B)(4)). DURING THE PROCEDURE, THE HANDPIECE MADE AN ABNORMAL NOISE AND OVERHEATED. THE DENTIST FOUND BURN INJURIES ON AND AROUND THE PATIENT'S LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215139 NSK MOTOR, DRILL, ELECTRIC HBC NAKANISHI INC. A235S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other