BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONIC FOCUS

    MDR report key: 3161413 · Received June 7, 2013

    Report

    Report Number
    3161413
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253226 HARMONIC FOCUS ELECTROSURGICAL, CUTTING AND COAGULATION GEI STRYKER SUSTAINABILITY SOLUTIONS * 2454887

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR