BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK

    MDR report key: 6989544 · Received October 31, 2017

    Report

    Report Number
    9611253-2017-00057
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    November 14, 2016
    Report Date
    May 29, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NAKANISHI TOOK THE FOLLOWING ACTIONS TO OBTAIN INFORMATION ABOUT THE PATIENT AND WHETHER OR NOT THE DEVICE WOULD BE RETURNED FOR EVALUATION. HOWEVER, NAKANISHI DID NOT RECEIVE ANY FURTHER INFORMATION. - ON OCTOBER 26, 2017 AND FEBRUARY 10, 2018, NAKANISHI SENT E-MAILS TO THE LOCAL DISTRIBUTOR, NSK AMERICA (NAM) FOR THE INFORMATION. NO RESPONSE WAS RECEIVED. - DURING A N(B)(6) QA MANAGER ASKED NAM QA MANAGER TO TRY TO OBTAIN THE INFORMATION. - ON MARCH 7, 2018, THE CONSULTING COMPANY SENT AN E-MAIL TO NAM ON THIS ISSUE ON BEHALF OF NAKANISHI. - ON MARCH 8, 2018, NAM RETURNED AN E-MAIL STATING NO FURTHER INFORMATION WAS AVAILABLE ABOUT THE PATIENT OR AVAILABILITY OF THE DEVICE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    WHEN NAKANISHI RECEIVED THE EVENT INFORMATION ON (B)(6) 2017, THE PATIENT IDENTIFIER WAS NOT DISCLOSED AS CONFIDENTIAL. DUE TO THE DEVICE NOT BEING RETURNED FROM THE USER FACILITY AT THIS POINT, (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

    ON (B)(6) 2017, NAKANISHI RECEIVED AN E-MAIL FROM A CONSULTING COMPANY (KBC) STATING THAT A USER FACILITY HAD SUBMITTED AN MDR REPORT TO FDA ABOUT NSK HANDPIECES. A COPY OF THE MDR REPORT WAS ALSO ATTACHED TO THE E-MAIL. IN THE MDR REPORT, TWO X85L HANDPIECES (SERIAL NO. (B)(4)) ARE REPORTED AS THE DEVICES INVOLVED IN THE FOLLOWING EVENT. ONE OF THE HANDPIECES OVERHEATED AND CAUSED THE EVENT, BUT THE DENTIST COULD NOT IDENTIFY WHICH DEVICE ACTUALLY DID. THE DETAILS OF THE EVENT INCLUDED IN THE USER FACILITY REPORT ARE; THE EVENT OCCURRED ON (B)(6) 2016. A PATIENT WAS UNDERGOING A PHARYNGEAL FLAP AND DENTAL REHABILITATION FOLLOWING A FLAP SURGERY. THE DRILL ATTACHMENT OF THE HANDPIECE OVERHEATED AND CAUSED AN EXTENSIVE BURN OF THE PATIENT'S LOWER RIGHT LIP AND TONGUE. NAKANISHI IS SUBMITTING TWO SEPARATE MDRS FOR THIS EVENT. THIS MDR IS REGARDING THE HANDPIECE WITH THE SERIAL NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769460 NSK HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI INC. X85L

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Hospitalization| O| R