BEUDAMED
    FDA Adverse Event Injury Summary report: N

    USA SERIES ACN - 2 FLEXIBLE CYSTONEPHROSCOPE

    MDR report key: 2762487 · Received September 24, 2012

    Report

    Report Number
    1218764-2012-00003
    Event Type
    Injury
    Date Received
    September 24, 2012
    Date of Event
    July 23, 2012
    Report Date
    July 25, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FBO
    PMA / PMN Number
    K904797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP 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

    GYRUSACMI WAS INFORMED THAT 2 PTS HAD URINARY TRACT INFECTIONS AFTER USE OF THIS SCOPE. THE CUSTOMER USES A BRUSH AND WAVICIDE TO DISINFECT. THEY HAVE BEEN STERILIZING THE SAME WAY FOR 20 YEARS WITH NO PROBLEMS. THE PTS WERE CLEARED OF THE INFECTIONS WITH ANTI-BODIES ALONE. NO OTHER DETAILS WERE GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA SERIES ACN - 2 FLEXIBLE CYSTONEPHROSCOPE FLEXIBLE CYSTONEPHROSCOPE-T FBO GYRUS ACMI, INC. ACN-2T

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK