BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK X95L

    MDR report key: 4212556 · Received October 24, 2014

    Report

    Report Number
    9611253-2014-00019
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    June 2, 2014
    Report Date
    October 23, 2014
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (X95L, SERIAL NO. (B)(4)). NAKANISHI INC. CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING OR TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. (B)(6)CONCLUSION: MAINTENANCE ISSUE - WEARING / ROUGHNESS OF THE BEARINGS MAY BE DUE TO IMPROPER OR LACK OF MAINTENANCE. (B)(6) DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVALUATION.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM (B)(6) TO NAKANISHI INC (NSK), REGARDING A DEVICE MANUFACTURED BY NSK FOR (B)(6). (B)(6) EVENT SUMMARY: PROCEDURE OB FILLING ON #15. PATIENT NOTICE THE HEATING UP OF THE HANDPIECE (MALE PATIENT (B)(6)). WHITE PATCH (NICKEL SIZE) ON THE CHEEK. WATER WAS RUNNING AT THE TIME OF THE PROCEDURE. PROCEDURE WAS FINISHED WITH A DIFFERENT HANDPIECE. (B)(6) COMPLAINT REVIEW: (B)(4). PURCHASE DATE FOR THIS CUSTOMER - (B)(6) 2011; AGE - ABOUT 40 MONTHS. NO OTHER COMPLAINTS FOR THIS SERIAL NUMBER. (B)(6) INVESTIGATION: REPAIR HISTORY - THERE WAS NO REPAIR HISTORY RECORDS FOUND FOR THIS UNIT. SERVICE EVALUATION - THE UNIT WAS EVALUATED BY THE REPAIR DEPARTMENT. THE TECHNICIAN FOUND THAT THE CHUCK STRENGTH WAS POOR AND THE UNIT WAS HEATING UP A LITTLE. UPON FURTHER EXAMINATION, THE REPAIR TECHNICIAN FOUND THAT THE BEARINGS IN THE DOG CLUTCH AND DRIVE SHAFT WERE ROUGH. THE GASKET AND GEAR SET WERE REPLACED TO REPAIR THE UNIT, THE UNIT WAS TESTED AND RETURNED TO THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680260 NSK X95L HANDPIECE CONTRA AND RIGHT ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. X95L

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR