BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2593903 · Received May 23, 2012

    Report

    Report Number
    3007069406-2012-00093
    Event Type
    Other
    Date Received
    May 23, 2012
    Date of Event
    April 19, 2012
    Report Date
    April 24, 2012
    Manufacturer
    MEDTRONIC ADVANCED ENERGY LLC
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE NOTED A WHITE ASH AT THE DISTAL TIP OF THE HOUSING. THE HOUSING APPEARED TO BE BURNT AS PER THE REPORTED EVENT. A REVIEW OF THE LOT HISTORY RECORD (LHR) FOR THIS LOT NUMBER FOUND THAT THE DEVICE MET ASSEMBLY AND PRODUCT SPECIFICATIONS, NO ANOMALIES WERE FOUND DURING MANUFACTURING. CONCLUSIONS: BENCH TOP INVESTIGATION FOUND THAT THE SILICONE MATERIAL IN THE TONSIL TIP CAN WITHSTAND THE HIGH TEMPERATURES SEEN DURING NORMAL USE. WHEN EXPOSED TO TEMPERATURES IN EXCESS OF 400 DEGREES C, IT WILL BURN, LEAVING A WHITE ASH RESIDUE BUT WILL NOT GENERATE ANY FLAME. IT WAS DETERMINED THAT IN A HIGH OXYGEN ATMOSPHERE, AN ACTIVE TONSIL TIP CAN IGNITE THE OXYGEN AND BURN THE TONSIL TIP HOUSING. IT WAS NOT POSSIBLE TO REPRODUCE THE BURNT TONSIL TIP HOUSING UNDER NORMAL ATMOSPHERIC CONDITIONS. END OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A TONSILLECTOMY, A TONSIL TIP IGNITED. NO PATIENT 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 52727

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NOT AVAILABLE