BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK X95

    MDR report key: 4772366 · Received May 12, 2015

    Report

    Report Number
    9611253-2015-00077
    Event Type
    Injury
    Date Received
    May 12, 2015
    Report Date
    April 30, 2015
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM (B)(6) TO NAKANISHI INC. (NSK) REGARDING A DEVICE MANUFACTURED BY NSK. EVENT SUMMARY: NAKANISHI RECEIVED A COMPLAINT HANDPIECE, X95, SERIAL NUMBER (B)(4). ACCORDING TO THE DISTRIBUTOR, THIS HANDPIECE HAD BURNED A PATIENT. THIS VENT IS UNDER INVESTIGATION. NAKANISHI HAS REQUESTED ADDITIONAL INFORMATION FROM THE DISTRIBUTOR AND NOW IS WAITING FOR THE INFORMATION. HOWEVER, NAKANISHI HAS STARTED THE EVALUATION PROCESS OF THE RETURNED PRODUCT. NAKANISHI WILL SUBMIT ADDITIONAL INFORMATION INCLUDING RESULTS OBTAINED THROUGH THE INVESTIGATION AS A FOLLOW-UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310174 NSK X95 EGS NAKANISHI, INC. X95

    Patients

    Seq Age Sex Outcome Treatment
    1 Other