BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBLATOR II

    MDR report key: 2110527 · Received May 19, 2011

    Report

    Report Number
    2110527
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ARTHROCARE ENT
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE TONSILLECTOMY AND ADENOIDECTOMY, PHYSICIAN SAW THE BLACK SLEEVE OF THE COBLATOR BEGIN TO BURN AND IMMEDIATELY REMOVED THE COBLATOR FROM THE PATIENT. UPON FURTHER ASSESSMENT, THE PHYSICIAN NOTED THAT THE PATIENT WAS BURNED ON HIS ANTERIOR TONSIL IN AN AREA THAT THE PHYSICIAN DID NOT INTEND TO HAVE CONTACT WITH THE COBLATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBLATOR II SURGERY SYSTEM GEI ARTHROCARE ENT RF8000E *
    2 EVAC 70 XTRA PLASMA WAND GEI ARTHROCARE ENT * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR