BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2841485 · Received October 26, 2012

    Report

    Report Number
    3007069406-2012-00508
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    August 25, 2008
    Report Date
    August 25, 2008
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K102786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED BASED AS A RESULT OF A RETROSPECTIVE REVIEW OF MARKETING EVALUATIONS RECEIVED BY THE MANUFACTURER. THE PLASMABLADE USED IN THE REPORTED COMPLAINT WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE LOT HISTORY RECORD REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM A MARKET EVALUATION, WHILE THE SCRUB TECH WAS CLEANING CHAR OFF OF THE TIP OF THE 4.0 PLASMABLADE, THE END PADDLE PIECE PULLED OUT. THE UNIT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE 4.0 01080801

    Patients

    Seq Age Sex Outcome Treatment
    1 NI PULSAR GENERATOR: SERIAL NUMBER (B)(4)