BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2428924 · Received January 20, 2012

    Report

    Report Number
    3007069406-2012-00025
    Event Type
    Other
    Date Received
    January 20, 2012
    Date of Event
    July 7, 2009
    Report Date
    July 7, 2009
    Manufacturer
    PEAK SURGICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K083415
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012: THIS MDR IS BEING FILED BASED ON A RETROSPECTIVE REVIEW OF COMPLAINTS RECEIVED BY THE MFR. VISUAL INSPECTION OF THE RETURNED TIP CONFIRMED THE ESCHAR BUILD ON THE MATING LINE OF THE TWO PIECE HOUSING, THE ESCHAR NOTED WOULD INDICATE THE HEAT PRESENT AT THIS LOCATION. THE TONSIL TIP WAS DESIGNED TO BE INSERTED FULLY, AND MATE TO THE SUCTION PORT OF THE HAND PIECE OF THE PLASMABLADE TNA. FURTHER INVESTIGATION FOUND THAT THE EXCHANGEABLE TIP MAY NOT HAVE BEEN FULLY INSERTED ONTO THE HAND PIECE DURING USE, WHICH COULD RESULT IN ARCING THROUGH THE EXPOSED CONDUCTED SHAFT. INSPECTION OF THE LOT HISTORY RECORD DID NOT NOTE ANY ISSUE DURING MFG OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADE WAS NOT PROPERLY SEATED DURING SURGERY, RESULTING IN BURN TO THE PT'S TONGUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL, INC. PLASMABLADE TNA 11552

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other NOT AVAILABLE