BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORZA F5

    MDR report key: 4421368 · Received January 9, 2015

    Report

    Report Number
    9611253-2014-00034
    Event Type
    Malfunction
    Date Received
    January 9, 2015
    Date of Event
    November 11, 2014
    Report Date
    September 20, 2017
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE TRIED TO GET MORE INFO FOR THIS EVENT. WE ASKED B-USA TO GET MORE DETAIL INFO FROM PT ON (B)(6) 2014 BY E-MAIL. BUT WE COULD NOT GET ANY ADDITIONAL INFO UP TO NOW. AS AN INVESTIGATION APPROACH NAKANISHI INC., (B)(4) (MFR) EXAMINED THE DHR FOR DEVICE (FORZA F5, SN (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-USA. B-USA EVENT SUMMARY: CUSTOMER INDICATED THAT THE HANDPIECE OVERHEATED AND BURNED THE PATIENT'S LIP. CUSTOMER IMMEDIATELY SWITCHED TO ANOTHER HANDPIECE TO FINISH THE PROCEDURE WHEN PT COMPLAINED OF THE HEAT SO WERE ABLE TO FINISH THE PROCEDURE. THE BURN DID NOT LEAVE A MARK SO NOTHING HAD TO BE DONE, NO MEDICAL INTERVENTION WAS REQUIRED AND THEY DID NOT BELIEVE THERE WILL BE ANY PERMANENT SCARRING. NAKANISHI HAS REQUESTED ADDITIONAL INFO FROM B-USA REGARDING THIS EVENT VIA WRITTEN LETTER E-MAIL SENT 11/21/2014. B-USA DID NOT RETURN HANDPIECE TO NSK FOR THE MFR'S EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24045 FORZA F5 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. FROZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 50 MO