BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 7463628 · Received April 26, 2018

    Report

    Report Number
    9611253-2018-00022
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    March 7, 2018
    Report Date
    July 17, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NAKANISHI IS NOW TRYING TO OBTAIN FURTHER INFORMATION ABOUT THE EVENT INCLUDING THE PATIENT. THIS EVENT OCCURRED IN (B)(6), BUT SIMILAR PRODUCTS ARE MARKETED IN THE US UNDER K972569.

    Additional Manufacturer Narrative · 1

    NAKANISHI TOOK THE FOLLOWING ACTIONS TO OBTAIN THE PATIENT INFORMATION, HOWEVER NO INFORMATION WAS PROVIDED. ON APRIL 25, 2018, NAKANISHI CONTACTED THE DISTRIBUTOR (B)(4) VIA NSK (B)(4) FOR THE INFORMATION AND RECEIVED AN E-MAIL FROM (B)(4) STATING THAT (B)(4) FORWARDED THE "ADDITIONAL INFORMATION FORM" (INFORMATION REQUEST FORM) TO THE DENTIST. ON JUNE 22, 2018, NAKANISHI SENT AN E-MAIL TO (B)(4) TO ASK WHETHER OR NOT THE DENTIST HAD PROVIDED THE INFORMATION. NO RESPONSE WAS RECEIVED. SEVERAL DAYS LATER (EXACT DATE UNKNOWN), NAKANISHI MADE A PHONE CALL TO (B)(4) TO HEAR THE PROGRESS. NO ONE WAS AVAILABLE IN THE OFFICE. AFTER THE EVENT, THE DEVICE WAS RETURNED FROM THE DENTIST TO THE DISTRIBUTOR, REPAIRED BY THE DISTRIBUTOR AND SENT BACK TO THE DENTIST. THEREFORE, NAKANISHI COULD NOT EVALUATE THE ACTUAL DEVICE AND THE DHR EXAMINATION WAS THE ONLY INVESTIGATION APPROACH NAKANISHI TOOK. 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 · 1

    ON APRIL 6, 2018, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR (B)(4) ABOUT A HANDPIECE OVERHEATING. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2018. A DENTIST WAS PERFORMING A DENTAL PROCEDURE USING THE NANO95LS HANDPIECE (SERIAL (B)(4)). DURING THE PROCEDURE, THE HANDPIECE OVERHEATED AND BURNED A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309653 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. NANO95LS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other