BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USA SERIES AUR-7 FLEXIBLE URETEROPYELOSCOPE

    MDR report key: 2191343 · Received July 27, 2011

    Report

    Report Number
    1218764-2011-00005
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 27, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FGB
    PMA / PMN Number
    K904793
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVAL FOUND THE DEFLECTION SECTION WAS KINKED AND LEAKED, THE DEFLECTION ANGULATIONS WERE SEVERELY DEGRADED, DAMAGE IN THE PROXIMAL END OF THE SHAFT AND TWO BROKEN FIBERS IN THE FIELD OF VIEW. THE DOWNGRADE IN DEFLECTION PERFORMANCE IS CONTRIBUTED TO A COMBINATION OF THE KINKED DEFLECTION SECTION AND THE LEAK WHICH DEVELOPED IN THE DEFLECTION COVER. THE WORKING CHANNEL WAS INSPECTED FOR BLOCKAGE INSIDE OF THE CHANNEL BY RUNNING A GUIDE WIRE DOWN THE LENGTH OF THE CHANNEL BEGINNING AT THE BIOPSY PORT CHANNEL AND ENDING THROUGH THE OBJECTIVE HEAD OPENING. ALTHOUGH THE WIRE WAS ABLE TO BE PUSHED THROUGH THE ENTIRE LENGTH OF THE CHANNEL, AS EXPECTED RESISTANCE WAS MET ONCE THE GUIDE WIRE REACHED THE KINKED PORTION OF THE DEFLECTION SECTION. THIS INDICATES THAT THE DAMAGE IN THE SHAFT LOCATED 58-59 CM FROM THE DISTAL END HAS NOT CAUSED ANY ADD'L DAMAGE TO THE WORKING CHANNEL. THE FIELD OF VIEW DISPLAYED TWO BROKEN IMAGE FIBERS. THE IMAGE BUNDLES ARE MADE OF A FRAGILE FIBERGLASS THAT WAS DAMAGED BY THE KINK IN THE DEFLECTION SECTION AND THE DAMAGE IN THE PROXIMAL END OF THE SHAFT. REMOVAL OF THE DEFLECTION COVER REVEALED AND CONFIRMED THE ROOT CAUSE OF THE DEFLECTION FAILURE. THE SECOND, FOURTH, AND EIGHTH DEFLECTION TABS IN THE RING ASSEMBLY HAVE BEEN POPPED OUT OF ALIGNMENT. ONE OR MORE OF THESE TABS PUNCTURED THE THIN LAYER OF URETHANE 15036 DEFLECTION COVER CREATING THE LEAK WHICH ALLOWED MOISTURE INTO AND OUT OF THE SCOPE. BASED UPON THE RESULTS OF THIS EVAL, ALL OF THE DEFECTS FOUND WITHIN THE AUR-7 URETEROSCOPE (B)(4), ARE ATTRIBUTED TO MISUSE OF THE DEVICE. TO THE BEST OF OUR KNOWLEDGE, THERE IS NO MFG RELATED PROCESS WITH THIS SCOPE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE THE SURGEON WAS USING THE FLEXIBLE URETEROSCOPE IN THE LEFT URETER, THE TIP WAS CURVED (IN THE SHAPE OF A C) AND THE SURGEON WAS UNABLE TO GET THE TIP OF SCOPE TO STRAIGHTEN. SURGEON ATTEMPTED TO STRAIGHTEN WITH A GUIDE WIRE, HE REMOVED THE SCOPE WITHOUT MUCH DIFFICULTY. AFTERWARDS, THE PT WAS MOVED TO AN OPEN OPERATING ROOM FOR A LAPAROTOMY WITH REPAIR OF LEFT URETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA SERIES AUR-7 FLEXIBLE URETEROPYELOSCOPE FLEXIBLE URETEROPYELOSCOPE FGB GYRUS ACMI, INC. AUR-7

    Patients

    Seq Age Sex Outcome Treatment
    1