BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PKS OMNI

    MDR report key: 3139641 · Received May 29, 2013

    Report

    Report Number
    2183680-2013-00027
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    GYRUS MEDICA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K081766
    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 HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINED 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

    GYRUS (B)(4) WAS INFORMED ON (B)(6) 2013 THAT DURING A SURGICAL PROCEDURE IT WAS NOTICED MELTED INSULATION NEAR THE TOP OF THE DEVICE. WHEN THE DEVICE WAS ACTIVATED IT BEGAN SMOKING NEAR THE END OF THE SHEATH AND THE RUBBER MELTED. A NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237284 PKS OMNI OMNI GEI GYRUS MEDICA, INC. 970010PC JF517581

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK