BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 4512633 · Received February 9, 2015

    Report

    Report Number
    9611253-2015-00011
    Event Type
    Malfunction
    Date Received
    February 9, 2015
    Date of Event
    January 5, 2015
    Report Date
    July 10, 2018
    Manufacturer
    NAKANISHI, INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Removal / Correction Number
    9611253-060818-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE DEVICE NOT BEING RETURNED FROM THE DISTRIBUTOR, NAKANISHI INC., (B)(4) (MANUFACTURER) MADE THE DHR EXAMINATION AS THE INVESTIGATION APPROACH. AS A RESULT OF THE EXAMINATION, THE DHR INDICATED THAT NO PROBLEMS OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM (B)(4) TO NAKANISHI INC. (NSK), REGARDING A DEVICE MANUFACTURED BY NSK FOR(B)(4). (B)(4) EVENT SUMMARY: DR. WAS PERFORMING WISDOM TEETH EXTRACTION. DR. NOTICED THE HANDPIECE WAS HEATING UP AND STARTING TO BURN THE PATIENT. SHE NOW HAS A SMALL PEA SIZE WELT ON THE INNER LIP AT THE CORNER OF THE LIP. THERE WAS NO CLINICAL DELAY IN PROCEDURE. THE OFFICE EXPLAINED TO HER THAT THERE WAS A SMALL BURN IN THE INSIDE OF HER LIP AND THAT IT WOULD SCAB OVER WITH NO PERMANENT SCARRING. THEY GAVE HER AN ANTIBIOTIC AND TOLD HER THAT SHE DID NOT NEED TO BE REFERRED TO HER PRIMARY CARE PHYSICIAN. THE PATIENT WILL RETURN THIS WEEK FOR A FOLLOW UP EVALUATION, BUT THE OFFICE SEE'S NO FURTHER ISSUES WITH THE PATIENT. NAKANISHI HAS REQUESTED ADDITIONAL INFORMATION FROM B-USA REGARDING THIS EVENT VIA WRITTEN LETTER SENT (B)(4) 2015. (B)(4) DID NOT RETURN HANDPIECE TO NSK FOR THE MANUFACTURER'S EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91704 NSK HANDPIECE CONTRA AND RIGHT ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. SGS-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other