BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV600R

    MDR report key: 3354461 · Received September 4, 2013

    Report

    Report Number
    2951571-2013-00001
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    August 14, 2013
    Report Date
    September 3, 2013
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED FIBER WAS EXAMINED. FOUND NICK AT PROXIMAL END OF DISTAL PIECE OF FIBER WHICH CAUSED THE BREAKAGE. BELIEVED TO HAVE OCCURRED DURING HANDLING.

    Description of Event or Problem · 1

    DISTAL END OF FIBER OPTIC BROKE INSIDE PT DURING AN ENDOVENOUS PROCEDURE TO TREAT REFLUX (OF GSV). A SECOND INCISION WAS MADE TO RETRIEVE THE BROKEN PIECE. CUT DOWN WAS PERFORMED SUCCESSFULLY AND SUTURES PLACED TO CLOSE THE INCISION. CEPHALEXIN (ANTIBIOTIC) WAS PRESCRIBED. SUTURES WERE LATER REMOVED AND A FOLLOW-UP PROCEDURE SCHEDULED. NO COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437365 MODEL EV600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. EV600R 30213590

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention