BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORZA F5

    MDR report key: 4589605 · Received March 3, 2015

    Report

    Report Number
    9611253-2015-00018
    Event Type
    Malfunction
    Date Received
    March 3, 2015
    Date of Event
    January 29, 2015
    Report Date
    December 14, 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 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 INFORMATION IS FROM (B)(6) TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK FOR B-USA. B-USA EVENT SUMMARY: DOCTOR AND ASSISTANT WERE PERFORMING A CROWN PREPARATION. THERE WAS NO PROCEDURAL DELAY WITH THIS CASE. PATIENT MADE THEM AWARE THAT THE HANDPIECE WAS STARTING TO GET HOT. THERE WAS NO BURNING, BLISTERING OR INJURY TO THE PATIENT. NAKANISHI HAS REQUESTED ADDITIONAL INFORMATION FROM (B)(6) REGARDING THIS EVENT VIA WRITTEN LETTER SENT 02/13/2015. (B)(6) DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146918 FORZA F5 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR