BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENAPAX XL

    MDR report key: 24258793 · Received February 4, 2026

    Report

    Report Number
    MW5183301
    Event Type
    Injury
    Date Received
    February 4, 2026
    Date of Event
    October 3, 2025
    Report Date
    January 29, 2026
    Manufacturer
    SAPHENA MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    AT END OF SURGERY, DRAPES WERE REMOVED AND PT WAS NOTED TO HAVE THREE FULL-THICKNESS ONE-INCH ENDOSCOPIC THERMAL BURNS ALONG VEIN HARVEST PATH ON LEFT INNER THIGH. LEG WRAPPED WITH ACE WRAP. BURNS ADDED TO LDA AVALAR FOR FURTHER TRACKING / ASSESSMENT / TREATMENT AS NEEDED. IMPLICATED DEVICE NAME = SAPHENA MEDICAL VENAPAX XL, REF: VPX4000, LOT # 43LD9645, EXP: 02/12/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316527 VENAPAX XL ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI SAPHENA MEDICAL VPX4000 43LD9645

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male