BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LS 1S

    MDR report key: 4850462 · Received June 15, 2015

    Report

    Report Number
    9611253-2015-00090
    Event Type
    Injury
    Date Received
    June 15, 2015
    Report Date
    February 7, 2018
    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 INVESTIGATIONAL 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.

    Additional Manufacturer Narrative · 1

    ON OCTOBER 14, 2016, NAKANISHI HEARD FROM THE DISTRIBUTOR THAT NO ADDITIONAL INFORMATION REGARDING THE PATIENT WAS AVAILABLE. THE DISTRIBUTOR DOES NOT HAVE ANY INFORMATION ABOUT THE DATE WHEN THE EVENT OCCURRED.

    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
    389353 LS 1S HANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL EGS NAKANISHI, INC. (NSK) LS 1S

    Patients

    Seq Age Sex Outcome Treatment
    1 Other