BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK FORZA F5

    MDR report key: 4235598 · Received October 27, 2014

    Report

    Report Number
    9611253-2014-00021
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 11, 2017
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MFG OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCE IN THE DHR.

    Additional Manufacturer Narrative · 1

    ON OCTOBER 14, 2016, NAKANISHI HEARD FROM THE DISTRIBUTOR THAT NO ADDITIONAL INFORMATION REGARDING PATIENT WAS AVAILABLE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO IS FROM (B)(6) TO NAKANISHI INC. (NSK) REGARDING A DEVICE MANUFACTURED BY NSK FOR (B)(6). (B)(6) EVENT SUMMARY: WATER WAS BEING USED, CROWN PREP ON #31. DOCTOR NOTICED THE HANDPIECE WAS LOUDER AND THE BACK CAP WAS HOT, AND THAT THE PT HAD A SHITE SPOT ON PT'S TONGUE, ABOUT A BACK CAP SIZE, ON TOP RIGHT OF TONGUE. COMPLETED PROCEDURE, ADMINISTERED CHLORHEXIDINE, CANKER-X, PAIN MED RX. NO PERMANENT DAMAGE. LUBRICATE, STATIM 2000 AUTOCLAVE, AND THEN RUN BEFORE USE EACH TIME. (B)(6) COMPLAINT REVIEW: (B)(4) - NO OTHER COMPLAINTS FOR THIS SERIAL NUMBER. THE UNIT WAS PURCHASED 2 JANUARY 2013 SO WAS ABOUT 18 MONTHS OLD AT THE TIME OF THE COMPLAINT. (B)(6) INVESTIGATION: REPAIR HISTORY = THERE WAS NO PRIOR REPAIR RECORDS FOUND FOR THIS SERIAL NUMBER. WHEN THE REPAIR TECHNICIAN EXAMINED THE UNIT, THE TECHNICIAN FOUND THE DRIVESHAFT AND CARTRIDGE BEARINGS WERE ROUGH. THERE WAS INTERNAL CORROSION IN THE UNIT. THE GEAR SET AND GASKET WERE REPLACED AND THE UNIT WAS RETURNED TO THE CUSTOMER. UNABLE TO DUPLICATE COMPLAINT. INTERNAL CORROSION AND WORN/ROUGH BEARINGS AND DRIVESHAFT COULD OCCUR DUE TO IMPROPER OR A LACK OF LUBRICATION/MAINTENANCE. (B)(6) CONCLUSION: INTERNAL CORROSION AND WORN/ROUGH BEARINGS AND DRIVESHAFT COULD OCCUR DUE TO IMPROPER OR LACK OF LUBRICATION/MAINTENANCE. (B)(6) DID NOT RETURN HANDPIECE TO NSK FOR THE MFR'S EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681212 NSK FORZA F5 HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other