BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 8102341 · Received November 26, 2018

    Report

    Report Number
    9611253-2018-00057
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    August 15, 2018
    Report Date
    July 2, 2019
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    PMA / PMN Number
    K113655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016004. (B)(4). NAKANISHI IS NOW TRYING TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT INCLUDING THE PATIENT INFORMATION.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE DISTRIBUTOR, THE DENTIST REFUSED TO PROVIDE THE PATIENT'S ID AND WEIGHT. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI INC., JAPAN (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 · 0

    ON OCTOBER 25, 2018, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT A PATIENT'S ACCIDENTAL INGESTION OF A DENTAL BUR. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2018. THE DENTIST WAS PERFORMING DENTAL RESTORATIONS ON A PATIENT USING THE TI-MAX X500KL HANDPIECE (SERIAL NO. (B)(4)). DURING THE PROCEDURE, THE BUR ATTACHED TO THE HANDPIECE SUDDENLY CAME OUT AND THE PATIENT SWALLOWED THE BUR. THE PATIENT WAS SENT TO A HOSPITAL TO GET CHEST X-RAYS.

    Description of Event or Problem · 0

    ON JUNE 11, 2019, NAKANISHI RECEIVED ADDITIONAL INFORMATION ON THE EVENT FROM THE DISTRIBUTOR.- THE PROCEDURE THE DENTIST WAS PERFORMING AT THE TIME OF THE EVENT WAS REMOVAL OF CARIOUS LESION.- THE PATIENT WAS UNDER ANESTHESIA (MILD SEDATION WITH NITROUS OXIDE).- THE CHEST X-RAYS FOUND THAT THE BUR DID NOT ENTER THE PATIENT'S LUNG.- THE DENTIST HAS FOLLOWED UP WITH THE PATIENT AND DETERMINED THAT THERE WAS NO FURTHER MEDICAL TREATMENT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940277 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. TI-MAX X500KL

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other