BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK

    MDR report key: 4407065 · Received January 6, 2015

    Report

    Report Number
    9611253-2014-00038
    Event Type
    Malfunction
    Date Received
    January 6, 2015
    Date of Event
    August 30, 2013
    Report Date
    July 10, 2018
    Manufacturer
    NAKANISHI, INC.
    Product Code
    KMW
    PMA / PMN Number
    K970953
    Removal / Correction Number
    9611253-060818-001-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS NOT RETURNED BY THE COMPLAINANT TO NAKANISHI INC., (B)(4) (MANUFACTURER) FOR A PHYSICAL EVALUATION/INVESTIGATION. THEREFORE AS OUR INVESTIGATIONAL APPROACH WE (NAKANISHI) EXAMINED THE DHR FOR DEVICE (SGA-E2G, 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.

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH NAKANISHI INC., (B)(4) EXAMINED THE DHR FOR DEVICE (SGA-E2G, 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.

    Description of Event or Problem · 1

    ON (B)(4) 2014 NSK AMERICA FORWARDED A REPORT TO NAKANISHI, INC. OF AN INJURY THAT MAY HAVE BEEN CAUSED BY A NSK HANDPIECE. THE INJURY WAS DESCRIBED AS A BURN LEAVING SIGNIFICANT SCARRING ON THE PATIENT'S LIP. THE NSK AMERICA INVESTIGATION REVEALED THE HANDPIECE WAS FOUND TO HAVE BEEN FIRST REPAIRED BY NSK AMERICA ON (B)(4) 2014. REVIEW OF THE REPAIR TECHNICIAN'S FINDINGS INDICATED THAT INADEQUATE MAINTENANCE WAS FACTOR IN THE FAILURE OF THE DEVICE DURING THESE REPAIRS. THIS HANDPIECE WAS ORIGINALLY SHIPPED TO (B)(4) ON (B)(4) 2009 FROM NAKANISHI INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9858 NSK HANDPIECE, ROTARY BONE CUTTING, KMW NAKANISHI, INC. SGA-E2G

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR