BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONTINUOUS FLOW RESECTOSCOPE INNER SHEATH

    MDR report key: 2163667 · Received June 13, 2011

    Report

    Report Number
    1519132-2011-00017
    Event Type
    Other
    Date Received
    June 13, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 13, 2011
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FDC
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE INSTRUMENT CONFIRMS THAT THE CERAMIC TIP HAS 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 AND HAS A PIECE MISSING FROM THE DISTAL RIM AND A CRACK CONTINUES FROM THE FRACTURE SITE TO THE BASE OF THE COMPONENT. NUMEROUS DENTS ARE ALSO NOTED ALONG THE LENGTH OF 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 DESCRIPTIONS 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 PROVEN 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 INSTRUCTION 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 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.

    Description of Event or Problem · 1

    DURING A PROSTATE SURGERY, WHILE USING THE CONTINUOUS FLOW RESECTOSCOPE INNER SHEATH, THE TIP FRACTURED OFF INTO THE BLADDER OF THE PT. THE SURGEON REMOVED THE PIECES BUT WAS UNSURE IF ALL THE MICRO PIECES WERE REMOVED, HE WAS NOT WORRIED AS HE WAS SURE THAT THEY WOULD FLUSH OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINUOUS FLOW RESECTOSCOPE INNER SHEATH CF RESECTOSCOPE FDC GYRUS ACMI, INC. EIS-HCF27

    Patients

    Seq Age Sex Outcome Treatment
    1