BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 6494003 · Received April 14, 2017

    Report

    Report Number
    9611253-2017-00016
    Event Type
    Injury
    Date Received
    April 14, 2017
    Date of Event
    February 27, 2017
    Report Date
    October 18, 2017
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    PMA / PMN Number
    K962543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN NAKANISHI OBTAINED THE DETAILED INFORMATION ON THE EVENT FROM (B)(4) ON (B)(6) 2017, THE PATIENT INFORMATION WAS NOT INCLUDED. ACCORDING TO THE DISTRIBUTOR, THE DENTIST REFUSED TO PROVIDE THE INFORMATION. ON (B)(6) 2017, NAKANISHI RECEIVED A PHONE CALL FROM THE DISTRIBUTOR SAYING THAT THE DEVICE INVOLVED IN THE EVENT WOULD NOT BE RETURNED. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI INC., (B)(4)(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.

    Additional Manufacturer Narrative · 1

    NAKANISHI HAS NOT RECEIVED ANY INFORMATION ABOUT THE PATIENT FROM THE DISTRIBUTOR. NAKANISHI WILL CONTINUE TO OBTAIN THE INFORMATION.

    Description of Event or Problem · 1

    ON APRIL 20, 2017, NAKANISHI RECEIVED DETAILED INFORMATION ON THE EVENT. THE EVENT OCCURRED ON (B)(6) 2017. THE PROCEDURE THE DENTIST WAS PERFORMING AT THE TIME OF THE EVENT WAS A MOLAR EXTRACTION. THE PATIENT WAS UNDER LOCAL ANESTHESIA. AFTER THE PATIENT SWALLOWED THE BUR, THE PATIENT WAS X-RAYED AND THE DOCTOR DETERMINED THAT THE BUR HAD BEEN NATURALLY ELIMINATED FROM THE PATIENT'S BODY AND NO ADDITIONAL TREATMENT WAS NECESSARY.

    Description of Event or Problem · 1

    ON MARCH 21, 2017, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT A PROBLEM WITH AN NSK HANDPIECE. DETAILS ARE AS FOLLOWS. - THE DATE WHEN THE EVENT OCCURRED IS UNKNOWN. - THE BUR WAS TESTED AND THERE WAS NO FAULT FOUND. - A DENTIST WAS PROVIDING A DENTAL TREATMENT FOR A PATIENT USING PHATELUS 45 TU (SERIAL NO. (B)(4)). - DURING THE PROCEDURE, THE BUR INSTALLED IN THE HANDPIECE CAME OFF AND THE PATIENT SWALLOWED THE BUR. - THE BUR WAS NOT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274647 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. PHATELUS 45 TU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other