BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2660739 · Received July 12, 2012

    Report

    Report Number
    3007069406-2012-00116
    Event Type
    Other
    Date Received
    July 12, 2012
    Date of Event
    June 21, 2012
    Report Date
    June 21, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TONSIL TIP IGNITION WAS REPORTED TO THE MANUFACTURER. THERE WAS A CUFFED ENDOTRACHEAL TUBE IN USE; ANESTHESIOLOGIST CONFIRMED THERE WAS NO LEAK OR AIRWAY LEAK. THERE WAS A MIXTURE OF OXIDATED GASES WITH 70% OXYGEN. NO PT IMPACT. THE PLASMABLADE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVAL. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TONSIL TIP IGNITED. NO PT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI MEDTRONIC ADVANCED ENERGY LLC PLASMABLADE TNA 54317

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR NOT AVAILABLE