BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENOM100MM MULTIGEN2 ELECTRODE

    MDR report key: 22675035 · Received July 31, 2025

    Report

    Report Number
    3015967359-2025-01331
    Event Type
    Malfunction
    Date Received
    July 31, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 19, 2025
    Manufacturer
    STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
    Product Code
    GXD
    UDI-DI
    07613327173680
    PMA / PMN Number
    K170242
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 9/19/2025, STRYKER INSTRUMENTS DISCONTINUED THE PRACTICE OF FILING MDRS FOR COMPLAINTS RELATED TO SHEATH BROKEN OFF, MISSING, OR FLAKING RESULTING IN THE THERMOCOUPLE BECOMING EXPOSED FOR DEVICES REGISTERED UNDER GXD PRODUCT CODE IN ACCORDING TO FDA'S "FINAL GUIDANCE ON MEDICAL DEVICE REPORTING FOR MANUFACTURERS" SECTION 2.15. THIS MALFUNCTION HAS NOT CAUSED OR CONTRIBUTED TO ANY SERIOUS INJURIES OR DEATHS IN AT LEAST TWO YEARS. NO NEW MDRS WILL BE FILED FOR THIS MALFUNCTION AND CORRECTED SUPPLEMENTAL MDRS WILL BE SUBMITTED IF NECESSARY FOR ANY EVENTS PENDING DEVICE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON FUNCTIONAL EVALUATION THE SHEATH WAS BROKEN OFF AND MISSING EXPOSING THE THERMOCOUPLE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Description of Event or Problem · 0

    NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56411 VENOM100MM MULTIGEN2 ELECTRODE GENERATOR, LESION, RADIOFREQUENCY GXD STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 07613327173680

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown