BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORZA F5

    MDR report key: 4740222 · Received April 28, 2015

    Report

    Report Number
    9611253-2015-00054
    Event Type
    Injury
    Date Received
    April 28, 2015
    Date of Event
    March 5, 2015
    Report Date
    April 27, 2015
    Manufacturer
    NAKANISHI INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH, NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR THE DEVICE (FORZA F5, SERIAL NO. (B)(4)). NAKANISHI CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. INVESTIGATION BY B-USA: THERE WERE TWO REPAIR HISTORIES FOUND FOR THE UNIT (IN (B)(6) 2013 AND IN (B)(6) 2013). BOTH CASES WERE RELATED TO BUR WALK-OUT AND CHUCK FAILURES. THE REPAIR DEPT EVALUATED THE UNIT BUT THE REPAIR TECHNICIAN COULD NOT REPLICATE THE COMPLAINT EVENT. CONCLUSION BY B-USA: AS THE DENTIST ACKNOWLEDGED, THE HANDPIECE WAS USED WITHOUT WATER DURING THE OPERATION. THE USAGE WITHOUT WATER MAY HAVE CAUSED THE OVERHEATING OF THE UNIT. THE REPAIR TECHNICIAN REPLACED THE GEAR SET AND GASKET OF THE UNIT, AND RETURNED IT TO THE DENTIST. B-USA DID NOT RETURN THE UNIT TO NAKANISHI (MANUFACTURER) FOR EVAL. AS OF THIS REPORT, NAKANISHI HAS NOT OBTAINED ANY ADDITIONAL INFO.

    Description of Event or Problem · 1

    THE FOLLOWING INFO IS FROM (B)(6) TO NAKANISHI REGARDING A DEVICE MANUFACTURED BY NAKANISHI FOR B-USA. EVENT SUMMARY BY (B)(4): WHILE THE DENTIST PLACED FILLING AND SHAVED IT DOWN FOR A PT, SHE NOTICED THAT THE HANDPIECE HAD OVERHEATED AND LEFT A QUARTER-SIZED BLISTER ON THE PATIENT'S TONGUE. THE DENTIST ACKNOWLEDGED THAT THE WATER WAS OFF DURING THE OPERATION. THE DENTIST HAS NOT SEEN THE PT SINCE THIS EVENT, BUT THE PATIENT'S MOTHER VISITED THE DENTIST OFFICE AND SAID THAT THE PT HAD TO VISIT AN ORAL SURGEON, WHO TREATED THE PT WITH A TOPICAL OINTMENT AND PRESCRIBED A Z-PAK. COMPLAINT REVIEW BY B-USA: THERE WERE NO PRIOR COMPLAINTS FOR THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277497 FORZA F5 EGS NAKANISHI INC. (NSK) FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other