BEUDAMED
    FDA Adverse Event Other Summary report: N

    US ELITE SYSTEM ELEMENTS

    MDR report key: 2163625 · Received June 10, 2011

    Report

    Report Number
    1519132-2011-00014
    Event Type
    Other
    Date Received
    June 10, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 10, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Adverse Event
    Yes
    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 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

    A TRANSURETHRAL ELECTRO-RESECTION OF THE PROSTATE PROCEDURE WAS BEING PERFORMED WITH THE ROLERBALL VAPORIZATION, USING THE WORKING ELEMENT, RESEC TRODE, AND ACTIVE CORD. INTRO-OPERATIVELY, THE SURGEON EXPERIENCED A SHOCK AND SPARKS WERE SEEN BY THE SURGEON ON THE BACK END OF THE SCOPE. NO BURNS WERE EXPERIENCED BY THE PT OR THE SURGEON. CROSS-REFERENCE MEDWATCH #3006159227-2011-00004 AND 1519132-2011-00015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 US ELITE SYSTEM ELEMENTS US ELITE SYSTEM ELEMENTS HIH GYRUS ACMI, INC. EMWE

    Patients

    Seq Age Sex Outcome Treatment
    1