BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEKTRAFUSE HF GENERATOR BIPOLAR

    MDR report key: 4213915 · Received October 6, 2014

    Report

    Report Number
    2916714-2014-00779
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    AESCULAP AG AND CO. KG
    Product Code
    GEI
    PMA / PMN Number
    K130596
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    US REPORTING AGENT NOTIFIED ON: (B)(4) 2014. MFG SITE EVAL: VISUAL INSPECTIONAL THE GENERATOR SHOWS NO OUTWARD DAMAGES. END OF LINE TESTING (TESTS THAT ARE PERFORMED FOLLOWING MFR) WAS PERFORMED, AND THE RESULTS WERE COMPARED TO THE END OF LINE TEST RESULTS THAT WERE ARCHIVED PRIOR TO RELEASE OF THE DEVICE FOLLOWING MFG. THERE WERE NO DEVIATIONS OF SPEC AND RESULTS NOTED. THE DEVICE OPERATES AS INTENDED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(4). DOES NOT COMPLETELY SEAL BLOOD VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625114 LEKTRAFUSE HF GENERATOR BIPOLAR SEAL AND CUT ACCESSORY GEI AESCULAP AG AND CO. KG GN200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other