BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING CONT. FLOW RESECTOSCOPE INNER SHEATH

    MDR report key: 1732939 · Received June 7, 2010

    Report

    Report Number
    1519132-2010-00016
    Event Type
    Malfunction
    Date Received
    June 7, 2010
    Date of Event
    May 5, 2010
    Report Date
    June 7, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FED
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GYRUS ACMI, INC. RECEIVED A MAUDE EVENT REPORT GIVING US VERY LITTLE INFO REGARDING THIS COMPLAINT. AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT 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 TRANSURETHRAL RESECTION OF THE PROSTATE, A FOREIGN BODY WAS NOTED IN THE BLADDER. A PIECE OF THE ROTATING CONTINUOUS FLOW RESECTOSCOPE INNER SHEATH HAD DETACHED AND FALLEN INTO THE PT. THE PIECE WAS RETRIEVED FROM THE PT WITH NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING CONT. FLOW RESECTOSCOPE INNER SHEATH ROTATING CONT. FLOW RESECT. INNER SHEATH FED GYRUS ACMI, INC. ERIS-CF27 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1