BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 15602886 · Received October 14, 2022

    Report

    Report Number
    9611253-2022-00073
    Event Type
    Injury
    Date Received
    October 14, 2022
    Report Date
    October 14, 2022
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAME ADVERSE EVENT IN THIS REPORT HAS BEEN REPORTED TO THE FDA SEPARATELY BY THE DISTRIBUTOR, NSK AMERICA CORPORATION, UNDER REPORT NUMBER 1422375-2022-00044. THIS DEVICE IS SIMILAR PRODUCT AS K203791. DESPITE THE FOLLOWING ACTIONS THE DISTRIBUTOR (NSK AMERICA) TOOK FOR INFORMATION ABOUT THE ADVERSE EVENT, ANY INJURY, OR THE PATIENTS, THE DENTAL OFFICE DID NOT PROVIDE THE INFORMATION. ON (B)(6) 2022, NSK AMERICA MADE A PHONE CALL TO THE DENTAL OFFICE, BUT THE DENTIST OR THE ASSISTANT INVOLVED IN THE EVENT WAS NOT AVAILABLE AT THAT MOMENT AND LEFT A MESSAGE WITH NSK AMERICA'S CONTACT INFORMATION. THERE WAS NO RESPONSE FROM THE DENTAL OFFICE. ON THE SAME DAY, NSK AMERICA SENT AN EMAIL TO THE DENTAL OFFICE, BUT NO RESPONSE WAS RETURNED. ON (B)(6) 2022, NSK AMERICA MADE A PHONE CALL, BUT THE DENTIST OR THE ASSISTANT WAS NOT AVAILABLE AND ASKED THE FRONT DESK STAFF TO CALL NSK AMERICA. NSK AMERICA HAS RECEIVED NO PHONE CALL FROM THE DENTAL OFFICE.

    Description of Event or Problem · 0

    ON (B)(6) 2022, NAKANISHI BECAME AWARE OF A MALFUNCTION OF NSK COUPLERS THROUGH A COMPLAINT INPUT INTO THE COMPLAINT DATABASE BY A DISTRIBUTOR (NSK AMERICA). ACCORDING TO THE DISTRIBUTOR (NSK AMERICA), THEY RECEIVED A REPORT FROM ONE OF THEIR DISTRIBUTORS IN CANADA THAT THEIR CUSTOMER HAD REPORTED THAT PATIENTS WERE BEING SHOCKED BY TWO OF THEIR HANDPIECE COUPLERS ON (B)(6) 2022. THIS MDR IS REGARDING THE COUPLER WITH THE SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889284 NSK HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. KCL-LED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other