BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANGIODYNAMICS VENACURE 1470

    MDR report key: 22187630 · Received June 11, 2025

    Report

    Report Number
    MW5171335
    Event Type
    Other
    Date Received
    June 11, 2025
    Date of Event
    April 23, 2025
    Report Date
    June 2, 2025
    Manufacturer
    ANGIODYNAMICS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    I PERFORMED AN EVLT FOR A PATIENT IN APRIL. UNFORTUNATELY, THERE WAS A MALFUNCTION WITH THE LASER AND UNBEKNOWNST TO ME A PORTION OF THE LASER FIBER WAS RETAINED IN THE PATIENT. I DIAGNOSED THE RETAINED FOREIGN BODY ON A 1-WEEK ULTRASOUND FOLLOW UP. I THEN REMOVED THE FOREIGN BODY 2 DAYS LATER. I HAVE NEVER SEEN THIS IN MY CAREER AND WHEN I DID SOME RESEARCH, AFTER THE FACT, I SAW ONE CASE REPORT WITH A SIMILAR SITUATION OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814876 ANGIODYNAMICS VENACURE 1470 POWERED LASER SURGICAL INSTRUMENT GEX ANGIODYNAMICS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention