BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK FORZA F5

    MDR report key: 4235599 · Received October 27, 2014

    Report

    Report Number
    9611253-2014-00022
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 27, 2017
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATION APPROACH NAKANISHI, INC. (B)(4) (MFR) EXAMINED THE DHR FOR DEVICE (FORZA F5, SERIAL NO. (B)(4)). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURED DURING MFG OR TESTING OF THE SUBJECT DEICE, AS EVIDENCED 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). EVENT SUMMARY: CROWN PREPARATION ON #19, DRILL TOUCH TONGUE AND LEFT A 10 MM X 10 MM BURN. THE HANDPIECE LEFT A RED BURN IN PTS MOUTH. NO MED INTERVENTION REQUIRED. BURNS WERE RINSED WITH WATER. NO PERMANENT SCARRING. (B)(6) COMPLAINT REVIEW: (B)(4) - NO OTHER COMPLAINTS FOR THIS SERIAL NUMBER. THE UNIT WAS PURCHASED (B)(4) 2014 SO WAS ABOUT 3 MONTHS OLD AT THE TIME OF THE COMPLAINT. (B)(6) INVESTIGATION: REPAIR HISTORY = THERE WAS NO PRIOR REPAIR RECORDS FOUND FOR THIS SERIAL NUMBER. SERVICE EVALUATION = THE RETURNED UNIT WAS EVALUATED BY THE REPAIR DEPARTMENT. THE TECHNICIAN TESTED THE HANDPIECE, BUT THE UNIT DID NOT HEAT UP. A SECOND TECHNICIAN ALSO CHECKED THE UNIT TO VERIFY AND THE UNIT DID NOT HEAT UP. THE UNIT WAS DISASSEMBLED AND THE PARTS EXAMINED. THE DOG CLUTCH, DRIVESHAFT, CARTRIDGE AND HEAD CAP BEARINGS WERE ALL FREE AND NOT BINDING. THE GEAR SET, GASKET AND HEAD CAP WERE REPLACED AND THE UNIT WAS RETURNED TO THE CUSTOMER. UNABLE TO DUPLICATE COMPLAINT. THE OPERATIONS MANUAL FOR THIS UNIT NOTES THAT OVERHEATING MAY BE CAUSED BY DEPRESSING THE PUSH BUTTON WHILE THE UNIT IS ROTATING AND THE USER SHOULD EXERCISE CAUTION TO ENSURE THE UNIT DOES NOT TOUCH CHEEK, TONGUE, OR OTHER TISSUE. (B)(6) CONCLUSION: UNABLE TO DUPLICATE COMPLAINT. UNIT DID NOT OVERHEAT FOR TWO TECHNICIANS. OVERHEATING MAY BE CAUSED BY DEPRESSING THE PUSH BUTTON WHILE THE UNIT IS ROTATING. (B)(6) DID NOT RETURN HANDPIECE TO NSK FOR THE MFR'S EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681446 NSK FORZA F5 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other