BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK X85L

    MDR report key: 4212537 · Received October 24, 2014

    Report

    Report Number
    9611253-2014-00015
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    November 20, 2013
    Report Date
    October 23, 2014
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR DEVICE (X85L, 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: NO RECORD OF REPAIR; NOISY UNIT MAY INDICATE A MAINTENANCE ISSUE. (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: PATIENT BURNED DURING A CROWN PREPARATION #31. NICKEL SIZE BURN ON THE SIDE OF THE PATIENT'S TONGUE. NO PERMANENT SCARRING. DOCTOR NOTICED THE BURN, PATIENT NUMB. THE CUSTOMER NOTED THAT THE UNIT OVERHEATED AND BURNED (SEVERITY OF BURN NOT PROVIDED) A PATIENT'S TONGUE. THE ITEM WAS PURCHASED (B)(6) 2009, SO THE UNIT WAS ALMOST 53 MONTHS OLD AT THE TIME OF THE COMPLAINT. (B)(6) COMPLAINT REVIEW: THERE WAS NO REPAIR HISTORY ON FILE FOR THIS UNIT. (B)(6) INVESTIGATION: THE CUSTOMER NOTED THAT THE UNIT WOULD NOT BE REPAIRED, BUT WOULD BE TRADED IN TOWARDS A NEW HANDPIECE. THE (TRADE IN) UNIT WAS SENT IN THE REPAIR DEPARTMENT AND EVALUATED. THE REPAIR TECHNICIAN NOTED THAT THE UNIT DID NOT HEAT UP AT ALL WHEN CHECKED. THE TECHNICIAN DID FIND THAT THE CHUCK STRENGTH WAS POOR AND MAKING CLICKING NOISE. THE UNIT WAS REALLY LOUD AND THE COOL AND SPRAY WAS POOR AS WELL. THE UNIT WILL BE DISPOSED OF AND THE CUSTOMER PURCHASED A NEW HANDPIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679562 NSK X85L HANDPIECE, CONTRA AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) X85L BRA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other