BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK SGA-E2S

    MDR report key: 4892371 · Received July 2, 2015

    Report

    Report Number
    1422375-2015-00011
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Report Date
    June 16, 2015
    Manufacturer
    NAKANISHI INC.
    Product Code
    KMW
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015 NSK AMERICA RECEIVED A HANDPIECE (MODEL SGA-E2S SERIAL NUMBER (B)(4)) FROM DEALER FOR REPAIR. INCOMING COMMENTS STATED "OVER HEATING BURNT PATIENT LIP". IMMEDIATELY CONTACTED DEALER FOR DOCTOR INFORMATION. CONTACTED OFFICE MANAGER AT DR. OFFICE, RECEIVED CALL BACK FROM MANAGER. DURING CONVERSATION IT WAS STATED THE DOCTOR HAD BURNED TWO PATIENTS, ON TWO CONSECUTIVE DAYS WITH THE SAME HANDPIECE. NO INFORMATION PROVIDED ON PATIENTS OR DATE OF THE EVENT. ATTEMPTED CONTACT BY TELEPHONE AND EMAIL ON (B)(6) 2015, (B)(6) 2015 AND (B)(6) 2015 NO RESPONSE AND FURTHER FOLLOW-UP'S WITH NO RESPONSE. ON (B)(6) 2015 RECEIVED EMAIL RESPONSE FROM MANAGER STATING OFFICE WAS CLOSED FOR VACATION. IN ADDITION, STATED THE DOCTOR WHO IS INVOLVED ONLY COMES INTO THE OFFICE ONE TIME PER MONTH NO INFORMATION WILL BE PROVIDED UNTIL HE IS AVAILABLE. (B)(6) 2015 HANDPIECE REPLACED AND FORWARDED TO NHQ FOR FULL EVALUATION. ON (B)(6) 2015 NO RESPONSE TO TELEPHONE ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431439 NSK SGA-E2S KMW NAKANISHI INC. SGA-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other