BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA-400CIII

    MDR report key: 4805666 · Received May 26, 2015

    Report

    Report Number
    9611253-2015-00063
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    July 24, 2013
    Report Date
    May 22, 2015
    Manufacturer
    NAKANISHI INC. (NSK)
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: NAKANISHI RECEIVED THE HANDPIECE ON (B)(6) 2013 AND CONDUCTED AN ANALYSIS AND INVESTIGATION. THE EVENT OCCURRED IN (B)(6), BUT THE SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K972563. 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 RETENTION FORCE OF THE OPERATING DEVICE ((B)(4)). THESE ACTIVITIES ARE DESCRIBED IN MORE DETAIL BELOW: METHODOLOGY USED: NAKANISHI EXAMINED THE DEVICE HISTORY RECORDS FOR THE REAMER DA-400CIII (SERIAL NUMBER (B)(4)). THERE WERE NO PROBLEMS OBSERVED DURING THE MANUFACTURING OR TESTING NOTED IN THE DHR. INITIAL INSPECTION: NAKANISHI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE AND PERFORMED A SIMPLE MOVEMENT TEST. THERE WERE NO VISIBLE ABNORMALITIES, SUCH AS CRACKS OR DEBRIS, ON THE OUTSIDE OF THE HANDPIECE. REPRODUCIBILITY TEST: NAKANISHI MOUNTED APPLICABLE REAMER TO THE SUBJECT HANDPIECE AND PULLED THE REAMER WITH FINGERS. IT WAS FOUND THAT THE REAMER DETACHED EASILY. DIMENSION CONFIRMATION: NAKANISHI CONFIRMED THAT THE SUBJECT REAMER WAS COMPLIANT WITH THE ISO STANDARD WITH THE CORRECT DIMENSION. OBSERVATION OF THE INSIDE OF THE HANDPIECE: NAKANISHI REMOVED THE HEAD CAP OF THE SUBJECT HANDPIECE TO OBSERVE THE INSIDE OF THE HEAD. IT WAS OBSERVED THAT ONE OF HOOKS WHICH ARE HOLDING A REAMER HAD BEEN BROKEN. NAKANISHI TOOK PHOTOGRAPHS TO CAPTURE THE BROKEN PART. NAKANISHI OBSERVED THE INNER SURFACE OF THE HEAD CAP PUSH BUTTON AND FOUND DAMAGE ON THE SURFACE. NAKANISHI TOOK PHOTOGRAPHS TO CAPTURE THE DAMAGED SURFACE. CONCLUSION REACHED: NAKANISHI BELIEVES THAT THE OBSERVED DAMAGE ON THE INNER SURFACE OF THE HEAD CAP PUSH BUTTON WAS CAUSED BY THE CONTACT WITH THE HOOKS DURING THE ROTATIONAL OPERATION, AND ONE OF THE HOOKS WAS BROKEN BY THIS CONTACT. THE REAMER DETACHED FROM THE HANDPIECE DUE TO THE DETERIORATED HOLING POWER CAUSED BY THE BROKEN HOOK. NAKANISHI REMINDED THE USER OF THE INSTRUCTION INCLUDED IN THE USER MANUAL: DO NOT PUSH THE BUTTON WHILE A HANDPIECE IS IN ROTATIONAL OPERATION AT A DENTAL OPERATION OR MAINTENANCE. MAKE SURE THAT A REAMER IS MOUNTED FIRMLY BEFORE EACH USE BY PULLING THE REAMER BY FINGERS.

    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 INFO THAT WE CAN OBTAIN FROM THE INITIAL COMPLAINANT. EVENT SUMMARY: ACCORDING TO THE DENTIST, A REAMER DETACHED FROM A HANDPIECE DURING A TREATMENT AND THE PT ACCIDENTALLY SWALLOWED THE REAMER. THIS PT VISITED A HOSP AND THE REAMER WAS REMOVED FROM THE STOMACH BY AN ENDOSCOPE. NO PHYSICAL PROBLEMS WERE OBSERVED WITH THE PT AFTER THE ENDOSCOPIC PROCEDURE. COMPLAINT REVIEW: REPAIR HISTORY = THIS HANDPIECE WAS REPAIRED AT NAKANISHI ON (B)(4) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340431 DA-400CIII NONE EGS NAKANISHI INC. (NSK) DA-400CIII

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other