BEUDAMED
    FDA Adverse Event Other Summary report: N

    VULCAN GENERATOR

    MDR report key: 305820 · Received November 20, 2000

    Report

    Report Number
    2953127-2000-00018
    Event Type
    Other
    Date Received
    November 20, 2000
    Date of Event
    October 6, 2000
    Report Date
    November 20, 2000
    Manufacturer
    ORATEC INTERVENTIONS, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER COMPLETION OF THE PROCEDURE (BILATERAL KNEE SCOPE), THREE BURNS WERE FOUND UNDER THE GROUNDING PAD ON THE PATIENT'S RIGHT SIDE (STOMACH AND PELVIC AREA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VULCAN GENERATOR RF GENERATOR GEI ORATEC INTERVENTIONS, INC. 815000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other