BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAC 70 XTRA HP PLASMA WAND

    MDR report key: 2191027 · Received July 29, 2011

    Report

    Report Number
    2951580-2011-00106
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 29, 2011
    Product Code
    GEI
    PMA / PMN Number
    K013463
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS REPORTED AS RETURNING FOR INVESTIGATION BUT HAS NOT BEEN RECEIVED TO DATE. A FOLLOW UP REPORT WILL PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING A TONSILLECTOMY PROCEDURE USING AN EVAC 70 HP PLASMA WAND, THE PT REPORTEDLY SUSTAINED A BURN ON HIS UPPER LIP. DETAILS REGARDING THE SEVERITY, SIZE OR TREATMENT OF THE BURN WERE NOT PROVIDED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAC 70 XTRA HP PLASMA WAND ELECTROSURGICAL CUTTING & COAGULATION DE GEI R431300-A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other| R