BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER PERIPHERALS DIODE LASER FIBER

    MDR report key: 641964 · Received October 14, 2005

    Report

    Report Number
    1221543-2005-00001
    Event Type
    Injury
    Date Received
    October 14, 2005
    Date of Event
    August 23, 2005
    Report Date
    October 13, 2005
    Manufacturer
    LASER PERIPHERALS LLC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TWO LASER FIBERS WERE POSITIONED (ONE IN THE GSV, THE OTHER IN THE GSV-ACCESSORY) WHEREBY THE FIRST LASER FIRED CONTINUOUSLY AND POSSIBLY CROSSED SUFFICIENTLY CLOSE TO THE OTHER FIBER SUCH THAT THE POLYMER WAS MELTED THROUGH AND THE QUARTZ FIBER BROKE OR BECAME BRITTLE AND SUBSEQUENTLY BROKE. THE ONLY WAY TO CONFIRM THIS IS TO EXCISE THE 3.8 CM LASER FIBER TIP FROM THE PATIENT AND ANALYZE THE FIBER TIP TO DETERMINE WHETHER MELTING OR BREAKAGE HAD OCCURRED. THE DOCTOR MADE AN INFORMED MEDICAL DECISION TO LEAVE THE LASER FIBER TIP IN VIVO WITHIN THE PATIENT SINCE IT IS INERT AND BIOCOMPATIBLE; EXCISION AT THE SFJ REGION COULD RESULT IN SIGNIFICANT BLEEDING, FISTULA FORMATION, INFECTION, AND MORE POTENTIAL MORBIDITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER PERIPHERALS DIODE LASER FIBER LASER FIBER GEX LASER PERIPHERALS LLC. DBLF-60 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention