BEUDAMED
    FDA Adverse Event Other Summary report: N

    USA ELITE SYSTEM SERIES ROLLER BALL ELECTRODE

    MDR report key: 2222865 · Received August 10, 2011

    Report

    Report Number
    3006159227-2011-00007
    Event Type
    Other
    Date Received
    August 10, 2011
    Date of Event
    June 13, 2011
    Report Date
    August 10, 2011
    Manufacturer
    GYRUS ACMI, INC
    Product Code
    GEI
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE ROLLER BALL ELECTRODE, PORTIONS OF THE BLACK COVERING OF THE SHEATH BECAME DETACHED FROM THE ELECTRODE AND FELL INTO THE PT. ALL REMNANTS OF THE ELECTRODES WERE REMOVED FROM THE PT WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE SYSTEM SERIES ROLLER BALL ELECTRODE ROLLER BALL ELECTRODE GEI GYRUS ACMI, INC RE

    Patients

    Seq Age Sex Outcome Treatment
    1