BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV600R

    MDR report key: 2806193 · Received October 23, 2012

    Report

    Report Number
    2951571-2012-00004
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 22, 2012
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: FIBER EXAMINED, CLEAN BREAK; NO SIGNS OF MISHANDLING.

    Description of Event or Problem · 1

    DISTAL END OF FIBER OPTIC BROKE INSIDE PT DURING AN ENDOVENOUS PROCEDURE TO TREAT REFLUX. A SECOND INCISION WAS MADE TO RETRIEVE THE BROKEN PIECE. CUT DOWN WAS PERFORMED SUCCESSFULLY, AND THE PROCEDURE WAS SUBSEQUENTLY RESUMED AND COMPLETED ON THE VEIN. VEIN IS CLOSED (TREATMENT SUCCESSFUL) WHEN EXAMINED AT 5-DAY FOLLOW-UP, AND PT DENIES CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL EV600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. EV600R C110190D

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention