BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK EX-6B

    MDR report key: 4690546 · Received April 8, 2015

    Report

    Report Number
    9611253-2015-00057
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Report Date
    April 6, 2015
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K962540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT REVIEW : THERE WAS NO REPAIR HISTORY ON FILE FOR THIS HANDPIECE. INVESTIGATION : THE HANDPIECE WAS FORWARDED TO THE MANUFACTURER FOR TESTING AND ANALYSIS ON OCT. 24, 2014. UPON RECEIPT FROM THE DENTIST OF THE DEVICE INVOLVED IN THE MDR EVENT. NAKANISHI CONDUCTED A FAILURE ANALYSIS OF THE RETURNED DEVICE THAT INCLUDED AN ATTEMPT TO MEASURE THE TEMPERATURE OF THE OPERATING DEVICE. THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW: METHODOLOGY USED : NAKANISHI EXAMINED THE DEVICE HISTORY RECORD FOR THE SUBJECT EX-66 DEVICE (SERIAL NUMBER (B)(4)). THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND PERFORMED SIMPLE MOVEMENT TEST. THERE WERE NO VISIBLE ABNORMALITIES, SUCH AS CRACKS OR DEBRIS, ON THE OUTSIDE OF THE HANDPIECE. NAKANISHI MEASURED THE TEMPERATURE OF THE HANDPIECE HEAD AND CONFIRMED THAT THE INCREASE OF THE TEMPERATURE WAS GREATER THAN THAT OF NORMAL HANDPIECE. HOWEVER, NAKANISHI DID NOT OBSERVE ANY ABNORMAL HEATING THAT WOULD INSTANTANEOUSLY CAUSE A BURN. IDENTIFICATION OF THE SPECIFIC FAILURE MODE(S) : NAKANISHI DISASSEMBLED THE HANDPIECE AND PERFORMED A VISUAL INSPECTION OF THE INSIDE PARTS AND FOUND NO CORROSION OR ACCUMULATED DIRT. HOWEVER, NAKANISHI OBSERVED WEAR ON A SLIDE RING AND PIN-PUSHING PIPE. CONCLUSIONS REACHED BASED ON THE INVESTIGATION AND ANALYSIS RESULTS : NAKANISHI BELIEVES THAT THE WEAR OBSERVED ON A SLIDE RING AND PIN-PUSHING PIPE WAS CAUSED BY FRICTION DUE TO CONTACT OF A SLIDE RING AND PIN-PUSHING PIPE DURING A ROTATING OPERATION. THEREFORE. NAKANISHI BELIEVES THAT THE DENTIST USED THE HANDPIECE WITHOUT TURNING THE BUR LOCK RING COMPLETELY OR THE DENTIST ACCIDENTALLY TURNED THE BUR LOCK RING DURING THE USE. THE HEAT CAUSED BY THE FRICTION DURING THE ROTATING OPERATION IS BELIEVED TO HAVE CAUSED THE OVERHEATING MALFUNCTION TO CAUSE PATIENT'S BURN INSTANTANEOUSLY.

    Description of Event or Problem · 1

    THIS MDR IS BEING REPORTED AT THIS TIME AS PART OF OUR INTERNAL REVIEW OF PAST COMPLAINTS AND SERVICE RECORDS. DUE TO THE INCIDENT BEING IN THE PAST, WE ARE LIMITED IN THE INFORMATION THAT WE CAN OBTAIN FROM THE INITIAL COMPLAINANT. THE FOLLOWING INFORMATION IS FROM A DISTRIBUTOR TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK. EVENT SUMMARY : ON (B)(6) 2014, NSK RECEIVED AN ELECTRIC DENTAL HANDPIECE MODEL EX-68, SERIAL NUMBER (B)(4) FOR REPAIR FROM THE DISTRIBUTOR REPAIR FACILITY. ON THE DISTRIBUTOR'S DOCUMENTATION WAS STATEMENT: PATIENT BURNED WITH THIS HANDPIECE. NSK DID NOT GET INFORMATION WHEN THE EVENT OCCURRED AND MORE DETAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230270 NSK EX-6B HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT,DENTAL, PRODUCT CODE: EGS EGS NAKANISHI, INC. (NSK) EX-6B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other