BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NSK Z85L

    MDR report key: 4740609 · Received April 28, 2015

    Report

    Report Number
    9611253-2015-00056
    Event Type
    Malfunction
    Date Received
    April 28, 2015
    Date of Event
    March 18, 2015
    Report Date
    April 27, 2015
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K972569
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATIONAL APPROACH, NAKANISHI, INC., (B)(6) (MFR) EXAMINED THE DHR FOR THE DEVICE (Z85L), SERIAL NUMBER (B)(4) NAKANISHI CONCLUDED THAT NO PROBLEMS HAD OCCURRED DURING MFG AND TESTING OF THE SUBJECT DEVICE AS EVIDENCED IN THE DHR.

    Description of Event or Problem · 1

    THE FOLLOWING INFO IS FROM BRASSELER USA (B-USA) TO NAKANISHI REGARDING A DEVICE MANUFACTURED BY NAKANISHI FOR B-USA. EVENT SUMMARY BY B-USA: A DENTIST NOTICED THAT THE HANDPIECE WAS STARTING TO HEAT UP AND INJURED THE INSIDE OF PT'S CHEEK WHILE PERFORMING A ROOT CANAL. ACCORDING TO THE DENTIST'S ASSISTANT, THE BURN DID NOT NEED MEDICAL ATTENTION OR AN ANTIBIOTIC OINTMENT BECAUSE IT WAS DETERMINED THAT BLISTERING OR SCARRING WOULD NOT OCCUR. THE DENTIST HAS NOT RETURNED THE UNIT TO B-USA. THE SUBJECT HANDPIECE HAS NOT BEEN RETURNED TO NAKANISHI FOR EVAL. NAKANISHI SALES PERSONNEL HAVE REQUESTED B-USA TO PROVIDE ADD'L INFO TO NAKANISHI ON THIS EVENT. AS OF THIS REPORT, NAKANISHI HAS NOT OBTAINED ANY ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277287 NSK Z85L HANDPIECE, CONTRA-AND RIGHT -ANGLE ATTACEMENT, DENTAL EGS NAKANISHI, INC. (NSK) Z85L

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR