BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NSK SGA-E2S

    MDR report key: 5633760 · Received May 5, 2016

    Report

    Report Number
    9611253-2014-00006
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    November 20, 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
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NAKANISHI INC. AS MANUFACTURER OF THE SGS-E2S DENTAL HANDPIECE IS UNABLE TO CONDUCT AN INVESTIGATION REGARDING THE DEVICE IN THIS EVENT DUE TO: THE DEVICE IN QUESTION WAS NOT RETURNED TO (B)(4), OUR IMPORTER OR TO NAKANISHI INC. DIRECTLY BY THE COMPLAINANT. NO SERIAL NUMBER WAS PROVIDED BY THE COMPLAINANT, SO NO EVALUATION OF THE DEVICE DHR COULD BE CONDUCTED. NAKANISHI CONDUCTED A REVIEW OF THE FDA MAUDE DATABASE AND WAS UNABLE TO LOCATE REPORT 9611253-2014-00006 (THIS REPORT). NAKANISHI BELIEVES THIS REPORT TO HAVE BEEN SUBMITTED PREVIOUSLY; HOWEVER NAKANISHI IS RE-SUBMITTING THIS REPORT TO ENSURE THAT FDA HAS A RECORD OF THE REPORT IN THE MAUDE DATABASE. DEVICE NOT RETURNED BY COMPLAINANT.

    Description of Event or Problem · 1

    ON (B)(6) 2014, (B)(4) A NAKANISHI INC. IMPORTER RECEIVED A TELEPHONIC COMPLAINT OF A HANDPIECE ALLEGEDLY CAUSING A BURN TO A PATIENT. COMPLAINANT ONLY PROVIDED THE MODEL NUMBER TO NSK AMERICA. THE SPECIFIC SERIAL NUMBER OF THE DEVICE INVOLVED IN THIS EVENT IS UNKNOWN. THE (B)(4) EMPLOYEE CONTACTED COLLECTED THE FOLLOWING INFORMATION FROM THE DOCTOR: HANDPIECE HEATED UP AND CAUSED A 2ND DEGREE BURN ABOUT 1CM AREA AND HEALING OF THE WOUND LEFT A SLIGHT SCAR. DENTAL PROCEDURE BEING PERFORMED WAS A WISDOM TOOTH EXTRACTION. PATIENT WAS AWAKE UNDER LOCAL ANESTHETIC. HANDPIECE WAS SENT FOR SERVICE BUT NOT SENT TO (B)(4). DOCTOR STATED REASON FOR DELAY IN REPORTING WAS THAT SHE WAS UNABLE TO FIND CONTACT INFORMATION FOR (B)(4). (B)(4) CHECKED THEIR INTERNAL SERVICE RECORDS AND DID NOT LOCATE ANY RECORDS OF THEM PERFORMING ANY REPAIR ACTIVITY FOR THIS DOCTOR. HANDPIECE SERIAL NUMBER WAS NOT KNOWN BY THE DOCTOR AND NO FURTHER RECORD SEARCHES COULD BE PERFORMED TO DETERMINE THE DATE OF SALE OF THE HANDPIECE TO THE DOCTOR. (B)(4) SENT A FOLLOW-UP LETTER REQUESTING ADDITIONAL INFORMATION AND RETURN OF THE HANDPIECE TO DR. (B)(6) ON (B)(6) 2014. AS OF SEPTEMBER 3, 2014 (B)(4) HAS RECEIVED NO RESPONSE FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290641 NSK SGA-E2S HANDPIECE, ROTARY BONE CUTTING KMW NAKANISHI INC. SGA-E2S

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention