BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EV 600 S

    MDR report key: 6441503 · Received March 28, 2017

    Report

    Report Number
    2951571-2017-00001
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    March 14, 2017
    Report Date
    March 28, 2017
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K062210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A 30 CM SEGMENT OF LASER FIBER WAS REMOVED FROM THE PATIENT BY A VASCULAR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223196 EV 600 S LASER FIBER GEX NEW STAR LASERS, INC. EV 600 S 898, 900, 905

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention