BEUDAMED
    FDA Adverse Event Other Summary report: N

    US ELITE ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 2474166 · Received February 23, 2012

    Report

    Report Number
    1519132-2012-00007
    Event Type
    Other
    Date Received
    February 23, 2012
    Date of Event
    January 27, 2012
    Report Date
    January 27, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FDC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INSTRUMENT CONFIRMS THAT THE CERAMIC TIP IS BROKEN OFF THE SHEATH TUBE. THE BROKEN PIECE OF CERAMIC WAS RETURNED WITH THE UNIT. A CRACK IS NOTED ON THE BROKEN PIECE OF CERAMIC. THE BALANCE OF THE CERAMIC TIP REMAINS SECURELY GLUED INSIDE THE DISTAL END OF THE SHEATH TUBE. ALSO NOTED ARE MULTIPLE DENTS ALONG THE STEEL TUBE. THE EXACT CAUSE OF THE BREAKAGE OF THE CERAMIC TIP CANNOT BE DETERMINED. DUE TO THE PRESENCE OF THE CRACK IN THE PIECE OF THE CERAMIC TIP THAT WAS RETURNED AND THE DENTS/DAMAGE ON THE STEEL TUBE AND THE FACT THAT THE ADHESIVE ON THE BASE OF THE TIP HAS RETAINED THE PROXIMAL PORTION IN THE TUBE, THE CAUSE OF THIS FAILURE IS DETERMINED TO BE CAUSED BY THE CUSTOMER. COMMON CAUSES OF CERAMIC TIP DAMAGE AS DETERMINED FROM PRIOR INVESTIGATIONS ARE NOTED BELOW: APPLICATION OF EXCESSIVE LATERAL FORCE ON THE INSTRUMENT DURING INSERTION OR REMOVAL FROM THE CYSTO SHEATH, WHICH FRACTURES THE CERAMIC AND CAUSES PIECES OF THE CERAMIC TO BREAK FROM THE TIP. DENTS OR OTHER DAMAGE TO THE STEEL TUBE ARE INDICATORS OF THIS TYPE OF MISUSE. PLEASE NOTE THAT THIS MISHANDLING IS CAUTIONED AGAINST IN THE INSTRUCTION FOR USE MANUAL THAT IS SHIPPED WITH THE INSTRUMENT. DROPPING THE INSTRUMENT OR HITTING THE TIP AGAINST OTHER INSTRUMENTS OR AGAINST STERILIZATION CONTAINERS IS ANOTHER COMMON CAUSE OF CERAMIC TIP BREAKAGE. THIS TYPE OF DAMAGE TO THE CERAMIC TIP CAN RESULT IN COMPLETE SEPARATION OF THE TIP CAN RESULT IN COMPLETE SEPARATION OF THE TIP OR POSSIBLY CHIPS OR CRACKS IN THE TIP THAT WILL LEAD TO FAILURE DURING SUBSEQUENT HANDLING OR USE. EXPOSURE OF LASER ENERGY TO THE CERAMIC TIP, WHICH CAN CAUSE OVERHEATING AND CRACKING/BREAKING OF THE CERAMIC MATERIAL.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, THE RESECTOSCOPE INNER SHEATH BROKE IN THE PT¿S BLADDER. THE SURGEON WAS ABLE TO RETRIEVE ALL PIECES WITH NO CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 US ELITE ROTATING CF RESECTOSCOPE INNER SHEATH ROTATING CF RESECTOSCOPE INNER SHEATH FDC GYRUS ACMI, INC. ERIS-CF25

    Patients

    Seq Age Sex Outcome Treatment
    1