BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 8471568 · Received April 1, 2019

    Report

    Report Number
    9611253-2019-00019
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    March 8, 2019
    Report Date
    March 12, 2020
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016004. (B)(4). ACCORDING TO THE DISTRIBUTOR, THE DENTIST REFUSED TO PROVIDE THE PATIENT'S WEIGHT, ETHNICITY AND RACE.

    Additional Manufacturer Narrative · 0

    ON FEBRUARY 21, 2020, NAKANISHI RECEIVED AN E-MAIL FROM (B)(4) CONTAINING ADDITIONAL INFORMATION. PER THE E-MAIL, (B)(4) COMMUNICATED WITH THE DENTIST OVER THE PHONE TO REQUEST THE RETURN OF THE DEVICE FOR INVESTIGATION ON MARCH 12, 2019. THE INSURANCE CARRIER ADVISED THE DENTIST TO RETAIN THE HANDPIECE AS POSSIBLE EVIDENCE, SO THE REQUEST WAS REFUSED. DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI CONDUCTED AN INVESTIGATION BY PERFORMING A DHR REVIEW. THE REVIEW INDICATED THAT NO PROBLEMS OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    ON MARCH 12, 2019, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR ((B)(4)) ABOUT A HANDPIECE OVERHEATING. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2019. THE DENTIST WAS PERFORMING A FILLING ON MOLARS #18 AND #19 OF THE PATIENT'S LOWER JAW USING THE Z95L HANDPIECE (SERIAL NO. (B)(4)). THE PATIENT WAS UNDER PROFOUND MANDIBULAR BLOCK ANESTHESIA. DURING THE PROCEDURE, THE DENTIST NOTICED BLISTERS ON THE PATIENT'S CHEEK AND TONGUE. ACCORDING TO THE DENTIST, THERE WERE NO ABNORMALITIES IN THE DEVICE OBSERVED PRIOR TO USE. AS OF MARCH 12, 2019, THE STATUS OF THE PATIENT'S INJURY WAS UNKNOWN, BECAUSE THE PATIENT REFUSED TO ALLOW THE DENTIST TO CONDUCT A FOLLOW UP VISIT AND HAS TAKEN HIS PATIENT RECORD FROM THE OFFICE. THE DENTIST REPORTED THAT THERE WOULD BE FURTHER MEDICAL ATTENTION NECESSARY TO TREAT THE BURN, BUT THE PATIENT HAS REFUSED FURTHER CARE FROM THE DENTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263277 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. Z95L

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other