BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST BIPOLAR

    MDR report key: 3031270 · Received August 15, 2006

    Report

    Report Number
    3031270
    Event Type
    Malfunction
    Date Received
    August 15, 2006
    Date of Event
    August 8, 2006
    Report Date
    August 14, 2006
    Manufacturer
    GYRUS MEDICAL INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    EVEREST BIPOLAR WAS NOT CUTTING TISSUE CORRECTLY ACCORDING TO DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVEREST BIPOLAR EVEREST BIPOLAR GEI GYRUS MEDICAL INC. NA 6003021

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR