BEUDAMED
    FDA Adverse Event Other Summary report: N

    PKS PLASMASPATULA ELECTRODE

    MDR report key: 2222579 · Received August 16, 2011

    Report

    Report Number
    2183680-2011-00028
    Event Type
    Other
    Date Received
    August 16, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 16, 2011
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    GEI
    PMA / PMN Number
    K041633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    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 LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE SURGEON EXPERIENCED ARCING FROM THE PLASMA SPATULA. COMPLETED THE PROCEDURE WITHOUT INCIDENT AND NO HARM TO THE PT OR SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PKS PLASMASPATULA ELECTRODE PLASMASPATULA ELECTRODE GEI GYRUS MEDICAL, INC. 952005PK

    Patients

    Seq Age Sex Outcome Treatment
    1