BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 16383360 · Received February 15, 2023

    Report

    Report Number
    9611253-2023-00012
    Event Type
    Injury
    Date Received
    February 15, 2023
    Date of Event
    December 13, 2020
    Report Date
    February 16, 2023
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT OCCURRED IN CHINA, BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K962543. ON (B)(6) 2023, NAKANISHI RECEIVED AN EMAIL FROM THE DISTRIBUTOR (NSK SHANGHAI) STATING THAT SINCE THE DEVICE INVOLVED IN THE EVENT HAD BEEN RETURNED TO THE DENTIST AND THE DENTIST DOESN'T OWN THE DEVICE NOW, THE DEVICE WAS NOT AVAILABLE FOR INVESTIGATION. ACCORDING TO THE DISTRIBUTOR, THE DENTIST REFUSED TO PROVIDE ANY FURTHER INFORMATION INCLUDING INFORMATION ABOUT THE PATIENT AND THE DEVICE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, NAKANISHI BECAME AWARE OF A MALFUNCTION OF A NSK HANDPIECE THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK SHANGHAI). DETAILS ARE AS FOLLOWS: THE EVENT OCCURRED ON (B)(6) 2020. A DENTIST WAS PERFORMING A DENTAL PROCEDURE FOR A DEEP CARIES CAVITY OF A PATIENT USING THE PANA-MAX2R M4 HANDPIECE (SERIAL NO. UNKNOWN). DURING THE PROCEDURE, THE BUR SUDDENLY LOOSENED AND CAME OFF FROM THE HANDPIECE IN THE PATIENT'S MOUTH AND THE PATIENT RECEIVED A WOUND ON THE LEFT SIDE OF THEIR TONGUE . HE WOUND REPORTED TO BE APPROXIMATELY 2MM WIDE AND 1MM DEEP IN SIZE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385457 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. PANA-MAX2R M4

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other