BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK FORZA 5

    MDR report key: 4212543 · Received October 24, 2014

    Report

    Report Number
    9611253-2014-00020
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 3, 2017
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (FORZA F5, SERIAL (B)(4)). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. (B)(6) CONCLUSION: UNABLE TO DUPLICATE COMPLAINT, BUT WORN BEARING COULD OCCUR DUE TO IMPROPER OR LACK OF LUBRICATION / MAINTENANCE. B-USA DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVALUATION.

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2016, NAKANISHI HEARD FROM THE DISTRIBUTOR THAT NO ADDITIONAL INFORMATION REGARDING PATIENT WAS AVAILABLE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM (B)(6) TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK FOR (B)(6). B-USA EVENT SUMMARY: PROCEDURE: INCISOR CROWN / VENEER PREP. PATIENT NOTICED FIRST THE HEAT. NO BLISTER. DOCTOR FINISHED THE PROCEDURE. NO MEDICINES ADMINISTERED. WATER WAS BEING USED IN THE PROCEDURE. B-USA COMPLAINT REVIEW: (B)(4) - NO OTHER COMPLAINTS FOR THIS SERIAL NUMBER. THE UNIT WAS PURCHASED (B)(4) 2012, SO WAS ABOUT 27 MONTHS OLD AT THE TIME OF THE COMPLAINT. B-USA INVESTIGATION: REPAIR HISTORY - THERE WERE 3 PRIOR REPAIR RECORDS FOUND FOR THIS SERIAL NUMBER. THE FIRST REPAIR WAS IN (B)(4) 2013 FOR MAKING A WHINING NOISE - UNITS WAS FOUND TO BE LOUD AND VIBRATED - REPAIRED AND RETURNED TO THE CUSTOMER. THE SECOND REPAIR WAS IN (B)(6) 2013 FOR BEARING FAILURE - UNIT WAS AGAIN FOUND TO BE LOUD AND VIBRATED - REPAIRED AND RETURNED TO THE CUSTOMER. THE THIRD REPAIR WAS IN (B)(6) 2014 FOR CHUCK FAILURE - AGAIN THE UNIT WAS FOUND TO BE LOUD AND VIBRATED AND THE BUR WALKED OUT OF THE CHUCK. THE GASKETS AND GEARSET WERE REPLACED TO REPAIR AND RETURNED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679558 NSK FORZA 5 HANDPIECE, CONTRA AND RIGHT ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) FORZA 5

    Patients

    Seq Age Sex Outcome Treatment
    1