BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 5852921 · Received August 8, 2016

    Report

    Report Number
    9611253-2016-00040
    Event Type
    Injury
    Date Received
    August 8, 2016
    Date of Event
    June 17, 2016
    Report Date
    July 10, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    PMA / PMN Number
    K970953
    Removal / Correction Number
    9611253-060818-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PATIENT WEIGHT WAS NOT INCLUDED IN THE INFORMATION ABOUT THE ADVERSE EVENT, NAKANISHI RECEIVED FROM THE DISTRIBUTOR ON JUNE 19, 2016, NAKANISHI SENT THE DISTRIBUTOR AN EMAIL FOR THE INFORMATION ABOUT THE PATIENT WEIGHT ON (B)(6) 2016. ACCORDING TO THE DISTRIBUTOR, THE DENTIST REFUSED TO PROVIDE THE INFORMATION. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, AN EXAMINATION OF THE DHR FOR DEVICE (H265 SGA-E2S 1:2 20 DEGREE ANGLE, SERIAL NO. (B)(4)) IS THE ONLY INVESTIGATION APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) CAN MAKE. AS A RESULT OF THE EXAMINATION, THE DHR INDICATED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    ON JUNE 19, 2016, NAKANISHI RECEIVED AN EMAIL FROM A DISTRIBUTOR ((B)(4)) STATING THAT A PATIENT WAS BURNED DUE TO A HANDPIECE OVERHEATING. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2016. THE DENTIST WAS SECTIONING A TOOTH DURING THE EXTRACTION OF WISDOM TEETH. THE DENTIST WAS AWARE OF THE UNIT OVERHEATING DURING THE PROCEDURE AND FOUND THE HANDPIECE HAD BURNED THE INSIDE OF THE PATIENT'S MOUTH. ACCORDING TO THE DENTIST, THE DAMAGE IS A POSSIBLE 2ND DEGREE BURN. THE DENTIST APPLIED BURN OINTMENT TO THE BURN INJURY IN THE PATIENT'S MOUTH. WHEN THE PATIENT VISITED THE DENTAL OFFICE ON (B)(6) 2016, THE DENTIST CONFIRMED THAT THE INJURY WAS STILL HEALING AND WAS NOT EXPECTED TO LEAVE ANY PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505462 NSK HANDPIECE, ROTARY BONE CUTTING KMW NAKANISHI INC. SGA-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Other