BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOPOLAR CABLE W/LG PIN, 10 FEET

    MDR report key: 1822042 · Received August 27, 2010

    Report

    Report Number
    2916714-2010-00005
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 23, 2010
    Manufacturer
    KIRWAN SURGICAL PRODUCTS, INC.
    Product Code
    GEI
    PMA / PMN Number
    K913514
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS BEING FORWARDED TO THE MFG SITE FOR EVAL.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOPOLAR CABLE W/LG PIN, 10 FEET GEI ELECTROSURGICAL, CUTTING & COAGULATION GEI KIRWAN SURGICAL PRODUCTS, INC. US354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention