BEUDAMED
    FDA Adverse Event Other Summary report: N

    USA ELITE SYSTEM ROTATING CONTINUOUS

    MDR report key: 2170183 · Received June 30, 2011

    Report

    Report Number
    1519132-2011-00018
    Event Type
    Other
    Date Received
    June 30, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 30, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INSTRUMENT CONFIRMS THAT THE CERAMIC TIP IS BROKEN OFF OF THE SHEATH TUBE. THE BALANCE OF THE CERAMIC TIP REMAINS SECURELY GLUED INSIDE THE DISTAL END OF THE SHEATH TUBE. THE BROKEN PIECE OF CERAMIC WAS RETURNED WITH THE UNIT. MINOR DENTS ARE ALSO NOTED ALONG THE LENGTH OF THE STEEL TUBE. THE EXACT CAUSE OF THE BREAKAGE OF THE CERAMIC TIP CANNOT BE DETERMINED. DUE TO THE PRESENCE OF THE DENTS ON THE TUBE AND THE FACT THAT THE MAJORITY OF THE CERAMIC TIP REMAINS SECURED IN THE INSTRUMENT, THE CAUSE OF THIS FAILURE IS DETERMINED TO BE DUE TO MISHANDLING. FURTHER DESCRIPTION OF POTENTIAL CAUSES OF THE MISUSE AND BREAKAGE ARE INCLUDED IN THE FOLLOWING ASSESSMENTS OBTAINED FROM A SEARCH OF PRIOR INCIDENTS FOR THIS TYPE OF INSTRUMENT: A BROKEN CERAMIC TIP HAS TYPICALLY BEEN PROVED TO BE CAUSED BY CUSTOMER MISUSE RESULTING FROM THE APPLICATION OF EXCESSIVE LATERAL FORCE ON THE INSTRUMENT DURING INSERTION OR REMOVAL FROM THE CYSTO SHEATH. PLEASE NOTE THAT THIS MISHANDLING IS CAUTIONED AGAINST IN THE INSTRUCTIONS FOR USE MANUAL THAT IS SHIPPED WITH THE INSTRUMENT. A SECOND POTENTIAL CAUSE OF BREAKAGE THAT CAN ALSO BE ASSOCIATED WITH CUSTOMER. MISUSE IS THAT OF DROPPING THE INSTRUMENT OR HITTING THE TIP AGAINST OTHER INSTRUMENTS OR AGAINST STERILIZATION CONTAINERS. THIS TYPE OF DAMAGE TO THE CERAMIC TIP CAN RESULT IN COMPLETE SEPARATION OF THE TIP OF OR POSSIBLY CHIPS OR CRACKS IN THE TIP THAT WILL LEAD TO FAILURE DURING SUBSEQUENT HANDLING OR USE.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE WHILE USING THE ROTATING CF RESECTOSCOPE, THE WHITE TIP BROKE AND FELL INTO THE PT, THE PIECE WAS REMOVED WITH NO HARM DONE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USA ELITE SYSTEM ROTATING CONTINUOUS ROTATING CF RESECTOSCOPE INNER SHEATH FJL GYRUS ACMI, INC. ERIS-CF27

    Patients

    Seq Age Sex Outcome Treatment
    1