BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE

    MDR report key: 2831310 · Received November 14, 2012

    Report

    Report Number
    1226420-2012-00059
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    GEI
    PMA / PMN Number
    K093695
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL METHOD: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. RESULTS: FACILITY DISPOSED OF DEVICE. DEVICE IS NOT AVAILABLE FOR RETURN AND INSPECTION. (B)(4).

    Description of Event or Problem · 1

    COAG MODE DOES NOT NOT FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE ELECTROSURGICAL DEVICE GEI MEDTRONIC ADVANCED ENERGY, LLC PS210-030SE 0205912113

    Patients

    Seq Age Sex Outcome Treatment
    1