BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 6192717 · Received December 21, 2016

    Report

    Report Number
    9611253-2016-00072
    Event Type
    Injury
    Date Received
    December 21, 2016
    Date of Event
    October 31, 2016
    Report Date
    June 14, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    ELC
    PMA / PMN Number
    K113530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NAKANISHI TOOK THE FOLLOWING ACTIONS TO OBTAIN INFORMATION ABOUT THE PATIENT AND THE PRODUCTION LOT NUMBER, AND WHETHER OR NOT THE DEVICE INVOLVED IN THE EVENT WOULD BE RETURNED FOR INVESTIGATION. HOWEVER, NAKANISHI COULD NOT RECEIVE ANY OF THE INFORMATION. ON JUNE 26, 2017, NAKANISHI SENT AN EMAIL TO NUK FOR THE INFORMATION. NUK RETURNED AN EMAIL STATING THAT: 1) THERE WAS NO INFORMATION ABOUT THE PATIENT AND THE LOT NUMBER. 2) THE SUBJECT DEVICE HAD NOT BEEN/WOULD NEVER BE RETURNED FROM THE USER. ON NOVEMBER 16, 2017, NAKANISHI SENT AN EMAIL TO NUK FOR THE INFORMATION. THERE WAS NO INFORMATION AVAILABLE. ON JANUARY 18, 2018, NAKANISHI HAD A CONVERSATION WITH THE NUK MANAGER DURING HIS VISIT TO NAKANISHI. NUK DID NOT HAVE THE INFORMATION. SINCE NAKANISHI DID NOT RECEIVE THE SUBJECT DEVICE AND THE LOT NUMBER, NAKANISHI COULD NOT TAKE ANY INVESTIGATION APPROACH, INCLUDING DHR EXAMINATION.

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2016, NAKANISHI IS STILL CONTACTING THE DISTRIBUTOR FOR MORE INFORMATION, INCLUDING PATIENT INFORMATION AND PRODUCT LOT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, NAKANISHI RECEIVED AN E-MAIL FROM A DISTRIBUTOR (NSK (B)(6)) ABOUT A FRACTURE OF AN NSK SCALER TIP. DETAILS ARE AS FOLLOWS. THE EVENT OCCURRED ON (B)(6) 2016. WHILE A DENTIST WAS PROVIDING A PATIENT WITH A DENTAL SCALING, THE NSK G5 SCALER TIP SUDDENLY FRACTURED IN THE PATIENT'S MOUTH. THE DENTIST TRIED TO FIND THE FRACTURED PORTION BUT COULD NOT LOCATE THE FRACTURED TIP. THE PATIENT WAS SENT TO A HOSPITAL FOR A CHEST X-RAY. THERE WAS NO FRACTURED TIP OBSERVED IN THE X-RAY IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843339 NSK SCALER, ULTRASONIC ELC NAKANISHI INC. G5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other