BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMABLADE TISSUE DISSECTION DEVICE

    MDR report key: 2110905 · Received March 18, 2011

    Report

    Report Number
    3007069406-2011-00009
    Event Type
    Other
    Date Received
    March 18, 2011
    Date of Event
    February 4, 2011
    Report Date
    February 23, 2011
    Manufacturer
    PEAK SURGICAL INC.
    Product Code
    GEI
    PMA / PMN Number
    K073057
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MFR HAS REQUESTED THAT THE DEVICE BE RETURNED FOR EVAL. THE MFR WILL FILE A F/U REPORT ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    EVENT DESCRIPTION FROM MDR FILED BY USER FACILITY: (B)(6). "EVENT DESC: DURING A TOTAL KNEE PROCEDURE, THE SURGEON WAS USING THE PLASMABLADE TO TRIM OFF SOME RESIDUAL CEMENT AROUND THE PLATE. THE POWER BUTTON WAS INADVERTENTLY ACTIVATED. A SMALL "CANDLE" FLAME WAS SEEN, BUT WAS IMMEDIATELY EXTINGUISHED WITH A WET SPONGE. THE SURGICAL SITE WAS IRRIGATED AND UPON INSPECTION, NO TISSUE DAMAGE OR BURN WAS NOTED. THERE IS NO KNOWN PT INJURY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. ORIGINAL INTENDED PROCEDURE: RIGHT TOTAL KNEE ARTHROPLASTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMABLADE TISSUE DISSECTION DEVICE GEI PEAK SURGICAL INC. PLASMABLADE 4.0 34844

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other NOT AVAILABLE