BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORZA F5

    MDR report key: 7536399 · Received May 23, 2018

    Report

    Report Number
    9611253-2018-00023
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    March 29, 2018
    Report Date
    June 27, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ON JUNE 2, 2018, NAKANISHI RECEIVED AN E-MAIL FROM THE DISTRIBUTOR STATING THAT THE DISTRIBUTOR WAS NOT ABLE TO OBTAIN INFORMATION ABOUT THE PATIENT'S WEIGHT, ETHNICITY AND RACE.

    Additional Manufacturer Narrative · 1

    NAKANISHI DID NOT RECEIVE INFORMATION ABOUT THE PATIENT WEIGHT. NAKANISHI WILL TRY TO CONTACT THE DISTRIBUTOR AGAIN FOR THE INFORMATION. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI INC., (B)(6) (MANUFACTURER) MADE THE DHR EXAMINATION AS THE INVESTIGATION APPROACH. AS A RESULT OF THE EXAMINATION, THE DHR INDICATED THAT NO PROBLEMS OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    ON MAY 1, 2018, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT AN NSK HANDPIECE OVERHEATING. ACCORDING TO THE DISTRIBUTOR, ONE OF THE FORZA F5 HANDPIECES (SERIAL NO. (B)(4)) OVERHEATED AND CAUSED THE FOLLOWING EVENT, BUT THE DENTIST COULD NOT IDENTIFY WHICH DEVICES ACTUALLY OVERHEATED. THE DETAILS OF THE EVENT ARE: THE EVENT OCCURRED ON (B)(6) 2018. THE DENTIST WAS PROVIDING A PATIENT WITH A CROWN PREPARATION USING THE FORZA F5. DURING THE PROCEDURE, THE HANDPIECE OVERHEATED AND BURNED THE PATIENT. THE DENTIST FOUND A BURN INJURY ABOUT THE SIZE OF THE HANDPIECE HEAD INSIDE THE PATIENT'S CHEEK. NO BURN TREATMENT WAS REQUIRED, BUT THE DENTIST RECOMMENDED THAT THE PATIENT RINSE WITH SALT WATER OR USE MEDICATED SALVE, IF NEEDED. THE PATIENT WAS SCHEDULED TO RETURN TO THE OFFICE ON (B)(6) 2018 FOR FOLLOW-UP. NAKANISHI IS SUBMITTING TWO SEPARATE MDRS FOR THIS EVENT BASED ON THE INFORMATION FROM THE DISTRIBUTOR. THIS MDR IS REGARDING THE HANDPIECE WITH THE SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381639 FORZA F5 HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. FORZA F5

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other