BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE FULGURATING ELECTRODE

    MDR report key: 2253534 · Received August 25, 2011

    Report

    Report Number
    1519132-2011-00021
    Event Type
    Other
    Date Received
    August 25, 2011
    Date of Event
    June 15, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FBO
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL 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 ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE ELECTRODE FELL APART. THE TIP OF THE DEVICE CAME OFF THE BODY OF THE ELECTRODE AND WAS DEEMED UNUSABLE BY THE SURGEON. THE DEVICE WAS TAKEN OFF THE STERILE FIELD. NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE FULGURATING ELECTRODE FLEXIBLE FULGURATING ELECTRODE FBO GYRUS ACMI, INC. 253F6

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR