BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLEXIBLE URETEROSCOPE

    MDR report key: 2440870 · Received January 31, 2012

    Report

    Report Number
    1218764-2012-00001
    Event Type
    Other
    Date Received
    January 31, 2012
    Report Date
    November 22, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FGB
    PMA / PMN Number
    K012925
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S COMPLAINT OF THE DISTAL TIP BREAKING INSIDE OF THE PT WAS CONFIRMED. THE EVALUATION OF THE RETURNED DUR-8 FOUND THAT THE SHORT BRAID IN THE SHAFT HAS BEEN TWISTED AND DAMAGE LIKELY DUE TO EXCESSIVE TORQUE. THE DAMAGE BRAIDS POKE SEVERAL HOLES IN THE DEFLECTION COVER CREATING SEVERAL SMALL LEAKS WITHIN THE COVER. THESE LEAKS ALLOWED MOISTURE INTO THE SCOPE WHICH ACCOUNTS FOR THE BUBBLE FOUND IN THE FIELD OF VIEW AND IN ADDITION TO THE DAMAGE TO THE SHORT BRAID HAS ALSO DEGRADED THE DEFLECTION ANGULATIONS. THE DISTAL BIOTHANE HAS ALSO BEEN PULLED BACK AWAY FROM THE DEFLECTION COVER AND THE PROXIMAL DISPLAYED INDICATIONS OF DETERIORATIONS. THIS IS DUE TO MISUSE BY CUSTOMER AND NOT A DEFECT IN OUR PRODUCT.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE FLEXIBLE URETEROSCOPE, THE TIP AT END OF CABLE BROKE OFF IN THE PT. THE TIP WAS RETRIEVED WITH NO HARM TO THE PT. NOTE: GYRUS ACMI REVIEWED OUR INITIAL DECISION NOT TO REPORT THIS EVENT AND DETERMINED THAT IT SHOULD HAVE BEEN REPORTED. THEREFORE, WE ARE ISSUING THE REPORT AT THIS TIME. WE HAVE INVESTIGATED THE CIRCUMSTANCES SURROUNDING THE ORIGINAL DECISION AND HAVE TAKEN APPROPRIATE ACTION TO ENSURE CORRECT DECISIONS GOING FORWARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXIBLE URETEROSCOPE FLEXIBLE URETEROSCOPE FGB GYRUS ACMI, INC. DUR-8

    Patients

    Seq Age Sex Outcome Treatment
    1