BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACN-2 FLEXIBLE CYSTONEPHROSCOPE

    MDR report key: 1661927 · Received April 16, 2010

    Report

    Report Number
    1218764-2010-00003
    Event Type
    Malfunction
    Date Received
    April 16, 2010
    Date of Event
    March 23, 2010
    Report Date
    April 16, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FBO
    PMA / PMN Number
    K904797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT HAS A FAST LEAK FROM THE WORKING CHANNEL AS WELL AS A STAIN IN THE IMAGE BUNDLE. DEFLECTION AND ILLUMINATION ARE BOTH GOOD. THE WORKING CHANNEL WAS BADLY DEGRADED. THE INSTRUMENT HAS THE "SPIRAL" WORKING CHANNEL DESIGN. THIS DESIGN HAS SINCE BEEN CHANGED BECAUSE IT RESULTS IN LEAKING AFTER CERTAIN TYPES OF STERILIZATION. THE OUTER COVERING OF THE WORKING CHANNEL IS PARTIALLY MISSING, COMPLETELY MISSING IN SOME AREAS. THIS IS MOST LIKELY THE SPRING THAT THE CUSTOMER IS REFERRING TO. THE SPIRAL IS COMPLETELY IN TACT ALONG THE ENTIRE LENGTH AND THERE IS NO PLACE WHERE IT COULD HAVE BEEN DETACHED AND LEFT IN THE PT. THE INSTRUMENT WAS OUT OF THE WARRANTY PERIOD.

    Description of Event or Problem · 1

    DURING A TURP PROCEDURE, THE SURGEON NOTICED A VERY FINE, THIN SPRING HAD FALLEN INTO THE PT. THE SURGEON REMOVED THE SPRING DURING AN OPEN PROCEDURE IN THE OPERATING ROOM. MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO REGARDING THE PT'S CONDITION HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1