BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV600R

    MDR report key: 2440796 · Received January 30, 2012

    Report

    Report Number
    2951571-2012-00001
    Event Type
    Injury
    Date Received
    January 30, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 30, 2012
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FIBER OPTIC USED TO DELIVER LASER ENERGY TO THE TREATMENT SITE BROKE INSIDE THE PT DURING TREATMENT FOR VENOUS INSUFFICIENCY, SPECIFICALLY FOR REFLUX OF THE GREAT SAPHENOUS VEIN (GSV). PHYSICIAN PERFORMED A CUT DOWN AND RETRIEVED THE FIBER. DURING A POST-OPERATIVE FOLLOW-UP, INCISIONAL REDNESS WAS NOTED AND BACTRIM WAS PRESCRIBED. AT A SUBSEQUENT FOLLOW UP, IT WAS NOTED THAT THE CONDITION WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL EV600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. EV600R 309110739M

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention