BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 600S

    MDR report key: 1273869 · Received December 24, 2008

    Report

    Report Number
    2951571-2008-00002
    Event Type
    Injury
    Date Received
    December 24, 2008
    Date of Event
    November 24, 2008
    Report Date
    December 23, 2008
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDOVENOUS PROCEDURE TO TREAT REFLUX OF THE GREAT SAPHENOUS VEIN (GSV), THE FIBER OPTIC PORTION OF THE DELIVERY SYSTEM BROKE INSIDE THE PATIENT. THE ENTIRE FIBER SEGMENT WAS REMOVED SURGICALLY BY THE PHYSICIAN USING SEVERAL SMALL INCISIONS. THE WOUND WAS SUCCESSFULLY TREATED WITHOUT FURTHER INCIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 600S FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. 600S LP505

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention