BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 1600R

    MDR report key: 708570 · Received May 3, 2006

    Report

    Report Number
    2951571-2006-00001
    Event Type
    Injury
    Date Received
    May 3, 2006
    Date of Event
    March 12, 2006
    Report Date
    May 3, 2006
    Manufacturer
    COOLTOUCH, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Description of Event or Problem · 1

    A MONTH PRIOR TO THE EVENT THE PT WAS TREATED FOR REFLUX OF THE GREAT SAPHENOUS VEIN USING ENDOVENOUS LASER ABLATION. A REUSABLE OPTICAL FIBER WAS USED FOR THE TREATMENT. AT THE FOLLOW-UP EXAMINATION, ULTRASOUND INSPECTION INDICATED A FOREIGN OBJECT IN THE GREAT SAPHENOUS VEIN DISTAL TO THE ACCESS SITE. A 2 CM. PIECE OF OPTICAL FIBER WAS IDENTIFIED AND REMOVED BY PHLEBOTOMY USING A SMALL NEEDLE. NO INFLAMMATION OR INFECTION WAS NOTED AND THE PT MADE AN UNREMARKABLE RECOVERY. THE OPTICAL FIBER USED IN THE PROCEDURE HAD BEEN DISCARDED AND WAS UNAVAILABLE FOR EXAMINATION. THE FIBER HAD BEEN REUSED APPROX FIVE TIMES ACCORDING TO MFR'S RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODEL 1600R LASER INSTRUMENT, SURGICAL, POWERED GEX COOLTOUCH, INC. 1600R UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention