BEUDAMED
    FDA Adverse Event Summary report: N

    NSK X95L

    MDR report key: 4942518 · Received July 21, 2015

    Report

    Report Number
    1422375-2015-00014
    Date Received
    July 21, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 24, 2015
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFO IS FROM NSK AMERICA, TO NAKANISHI REGARDING A DEVICE INVOLVED IN AN ADVERSE EVENT THAT OCCURRED IN U.S. EVENT SUMMARY BY NSK AMERICA: ON JUNE 24, 2015, NSK AMERICA RECEIVED A HANDPIECE (MODEL X95L, (B)(4)) FROM A DEALER FOR REPAIR. INCOMING COMMENTS STATED THAT THE HANDPIECE WAS OVERHEATED AND BURNT A PT'S MOUTH. A PICTURE WAS INCLUDED AND DATED (B)(6) 2015. NSK AMERICA IMMEDIATELY CONTACTED THE OFFICE AND SPOKE WITH THE OFFICE MANAGER. DURING CONVERSATION, THE OFFICE MANAGER STATED THAT THE HANDPIECE WAS HOT WHEN IT WAS TAKEN OUT OF THE AUTOCLAVE BAG. THE MANAGER HAD NO INFO IF THE HANDPIECE WAS ALLOWED TO COOL DOWN IN THE STERILIZATION PROCESS. INFO FORMS WERE SENT TO THE OFFICE. NSK AMERICA HAD RECEIVED NO RESPONSE. SEVERAL ATTEMPTS TO OBTAIN THE PT INFO OR THE DETAILED INCIDENT INFO WAS MADE BY TELEPHONE AND EMAIL. NO RESPONSE. JUNE 29, 2015 HANDPIECE WAS REPLACED TO PREVENT POSSIBLE LONG DELAY FOR EVAL AND RETURN. THE HANDPIECE WAS SENT TO NAKANISHI HEADQUARTERS FOR FULL EVAL. MFR # 9611253-2015-00102.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471462 NSK X95L HANDPIECE, CONTRA AND RIGHT ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. X95L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other