BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL EV600R

    MDR report key: 3810162 · Received March 4, 2014

    Report

    Report Number
    2951571-2014-00001
    Event Type
    Injury
    Date Received
    March 4, 2014
    Date of Event
    December 13, 2013
    Report Date
    March 4, 2014
    Manufacturer
    NEW STAR LASERS, INC.
    Product Code
    GEX
    PMA / PMN Number
    K040921
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIBER OPTICS FROM THE LOT REFERENCED IN THIS REPORT ARE PRODUCED BY ANOTHER COMPANY. THAT COMPANY RECEIVED SOME EXAMPLES OF THE BROKEN FIBERS DIRECTLY FROM THE DISTRIBUTOR. THE COMPANY INSPECTED THE FIBERS AND CONCLUDED THAT THERE WAS "OBVIOUS MECHANICAL DAMAGE" CAUSED BY THE PHYSICIAN OR PHYSICIAN'S STAFF AND THAT IT WAS NOT A MANUFACTURING DEFECT. NEW STAR LASERS WAS NOT INVOLVED IN THE EVALUATION OF THE PRODUCT IN QUESTION. INFO WAS DIFFICULT TO OBTAIN REGARDING THE EVENTS AND WAS AVAILABLE MUCH LATER THAN THE INITIAL REPORT. SAMPLES OF REMAINING INVENTORY WERE EVALUATED IN-HOUSE AND NO ISSUES FOUND.

    Description of Event or Problem · 1

    EVENT OCCURRED IN (B)(6) AND WAS REPORTED BY THE DISTRIBUTOR. A PHYSICIAN EXPERIENCED FIBER BREAKAGE WHILE PERFORMING AN ENDOVENOUS PROCEDURE USING LASER. SOME FIBERS BROKE BEFORE USE BUT THERE WERE A TOTAL OF FIVE OCCASIONS WHERE THEY BROKE INSIDE OF PATIENTS. FOR AT LEAST SOME OF THESE PATIENTS, THE DOCTOR RETRIEVED THE BROKEN PIECES VIA CUTDOWN. NO COMPLICATIONS WERE REPORTED, AND NO ADD'L INFO IS AVAILABLE ON THESE CASES. FIBER OPTICS WERE PRIMARILY SOLD OUTSIDE OF THE U.S. THERE HAVE BEEN NO OTHER REPORTS OF BREAKAGE FROM THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130493 MODEL EV600R FIBER OPTIC DELIVERY SYSTEM GEX NEW STAR LASERS, INC. EV600R 038131189M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention