BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LS 1S

    MDR report key: 4850463 · Received June 15, 2015

    Report

    Report Number
    9611253-2015-00096
    Event Type
    Injury
    Date Received
    June 15, 2015
    Report Date
    June 9, 2015
    Manufacturer
    NAKANISHI, INC. (NSK)
    Product Code
    EGS
    PMA / PMN Number
    K962540
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN INVESTIGATION APPROACH, NAKANISHI, INC., (B)(4) (MANUFACTURER) EXAMINED THE DHR FOR THE DEVICE (LS 1S , SN (B)(4)). NAKANISHI CONFIRMED THAT NO PROBLEMS HAD BEEN FOUND DURING THE MANUFACTURING AND TESTING OF THE SUBJECT DEVICE.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION IS FROM BRASSELER USA (B-USA) TO NAKANISHI REGARDING A DEVICE MANUFACTURED BY NAKANISHI FOR B-USA. EVENT SUMMARY BY B-USA: THE PROPHY ANGLE HANDPIECE LS 1S BURNED THE DENTIST'S HAND DUE TO HEATED-UP. COMPLAINT REVIEW BY B-USA: THERE WERE NO PRIOR COMPLAINTS FOR THE HANDPIECE. INVESTIGATION BY B-USA: THERE WERE NO PRIOR REPAIRS FOR THE SUBJECT HANDPIECE. B-USA HAS NOT RETURNED THE SUBJECT UNIT TO NAKANISHI (MANUFACTURER) FOR EVALUATION. HOWEVER, NAKANISHI HAS STARTED THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387185 LS 1S HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) LS 1S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other