BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAC 70 XTRA

    MDR report key: 2801014 · Received October 18, 2012

    Report

    Report Number
    3006524618-2012-00823
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 19, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K033257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT IDENTIFIER AND WEIGHT WERE NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE PERFORMING A ADENOTONSILLECTOMY, THE PHYSICIAN LAID THE SHAFT OF THE WAND ON THE ANTERIOR PILLAR, AND IT BURNED THE PILLAR. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAC 70 XTRA ELECTROSURGICAL CUTTING & COAGULATION DE GEI ARTHROCARE CORPORATION B219010-A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention