BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORZA F5

    MDR report key: 4359478 · Received December 8, 2014

    Report

    Report Number
    9611253-2014-00035
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    November 19, 2014
    Report Date
    September 28, 2017
    Manufacturer
    NAKANISHI, INC (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE TRIED TO GET MORE INFORMATION FOR THIS EVENT. WE ASKED B-USA TO GET MORE DETAIL INFORMATION FROM PATIENT ON (B)(4) 2014 BY E-MAIL. BUT WE COULD NOT GET ANY ADDITIONAL INFORMATION UP TO NOW. AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (FORZA F5, SERIAL NO. (B)(4)). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR.

    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). SUMMARY: DURING A BITE ADJUSTMENT, WITH WATER RUNNING THROUGH THE HANDPIECE, THE PT FELT DISCOMFORT. THE DOCTOR DETECTED IT WAS EVERY TIME THE HEAD CAP OF THE HANDPIECE TOUCHED THE PT'S TONGUE. DOCTOR FELT THE HANDPIECE AND IT WAS HOT. THE DOCTOR PULLED THE HANDPIECE FROM ROTATION AND FINISHED THE BITE ADJUSTMENT WITH A DIFFERENT HANDPIECE. NO OINTMENT APPLIED, NO LASTING BLISTER. THEY SPRAY THE HANDPIECE WITH LUBE AFTER EACH USE, PRIOR TO AUTOCLAVING IT. NAKANISHI HAS REQUESTED ADD'L INFO FROM (B)(4) REGARDING THIS EVENT VIA WRITTEN LETTER SENT (B)(4) 2014. B-USA DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792555 FORZA F5 HANDPIECE, CONTRA-AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC (NSK) FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR