BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N5000

    MDR report key: 5060048 · Received September 8, 2015

    Report

    Report Number
    9611253-2015-00110
    Event Type
    Injury
    Date Received
    September 8, 2015
    Date of Event
    July 22, 2015
    Report Date
    April 16, 2018
    Manufacturer
    NAKANISHI INC.
    Product Code
    EFB
    PMA / PMN Number
    K962543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH, NAKANISHI INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR THE DEVICE (N5000, (B)(4)). NAKANISHI CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MANUFACTURING AND TESTING OF THE SUBJECT DEVICE, AS EVIDENCED IN THE DHR. NAKANISHI CONTACTED THE DISTRIBUTOR ((B)(4)) TO OBTAIN THE INFORMATION ABOUT SERVICE HISTORY OF THE DEVICE, BECAUSE NAKANISHI CONSIDERED THE POSSIBILITY FROM MANY YEARS OF EXPERIENCE THAT THE HEADCAP HAD NOT BEEN FIRMLY FIXED AT THE TIME OF CARTRIDGE REPLACEMENT, SINCE THE N5000 DEVICE HAS A REPLACEABLE CARTRIDGE IN THE HEAD. ACCORDING TO (B)(4), THE DEVICE WAS PURCHASED (B)(6) 2014 AND REPAIRED TWICE (IN (B)(6) 2014 AND (B)(6) 2015). AND THE CARTRIDGE WAS REPLACED IN THE SERVICE. SERIAL NO. OF ORIGINAL CARTRIDGE : (B)(4). SERIAL NO. OF THE CARTRIDGE AT THE TIME OF EVENT : (B)(4). NAKANISHI WILL SEND AN AI REQUEST LETTER TO BSA AND CONTINUE THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ON OCTOBER 14, 2016, NAKANISHI HEARD FROM THE DISTRIBUTOR THAT NO ADDITIONAL INFORMATION REGARDING THE PATIENT WAS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, NAKANISHI WAS ADVISED BY (B)(4) OF A DEVICE MANUFACTURED BY NAKANISHI FOR (B)(4). (B)(4) RECEIVED A HANDPIECE RETURNED FOR REPAIR FROM A DENTIST. THERE WAS A NOTE ALONG WITH THE HANDPIECE INDICATING THAT A HEAD CAP HAD CAME OFF AND HAD BEEN SWALLOWED BY A PATIENT DURING A DENTAL PROCEDURE. THE DENTIST WAS ABLE TO FINISH THE PROCEDURE. THE DENTIST DETERMINED THAT - NO MEDICAL INTERVENTION IS REQUIRED - NO PERMANENT DAMAGE TO PATIENT IS EXPECTED. THERE IS NO INFORMATION ON WHETHER THE HEAD CAP HAS PASSED THROUGH AND OUT OF THE PATIENT. THERE IS ALSO NO DETAILED INFORMATION ABOUT THE PATIENT BECAUSE THE DENTIST DOES NOT REMEMBER THE STAFF MEMBER THAT WAS WORKING WITH THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593602 N5000 HANDPIECE, AIR-POWERED, DENTAL EFB NAKANISHI INC. N5000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other