BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CF RESECTOSCOPE

    MDR report key: 1912853 · Received November 9, 2010

    Report

    Report Number
    9617070-2010-00034
    Event Type
    Other
    Date Received
    November 9, 2010
    Date of Event
    October 14, 2010
    Report Date
    November 9, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE SEPARATION OF THE CERAMIC TIP FROM THE TUBE CANNOT BE DETERMINED. DUE TO THE PRESENCE OF THE RESIDUAL GLUE ON THE INSIDE OF THE TUBE, IT IS REASONED THAT THE TIP CAME LOOSE AS THE RESULT OF EXTERNAL FORCES BEYOND THE DESIGN INTENT OF THE DEVICE. FURTHER, DUE TO THE CHIPPED TIP AND CRACK DOWN THE LENGTH OF THE CERAMIC, IT IS REASONED THAT THE DEVICE WAS SUBJECT TO MISUSE BY THE USER. THIS IS ALSO SUPPORTED BY THE PRESENCE OF THE NUMEROUS DENTS ON THE TUBE. THUS, THE CAUSE OF THIS FAILURE IS MOST LIKELY 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 ABUSE 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. DENTS FOUND ALONG THE STEEL TUBE ARE OFTEN INDICATION THAT EXCESSIVE LATERAL FORCE HAS OCCURRED. A SECOND POTENTIAL CAUSE CAN ALSO BE ASSOCIATED WITH CUSTOMER ABUSE THAT OCCURS DUE TO IMPROPER HANDLING OF THE INSTRUMENT. IN SUCH CASES DROPPING THE INSTRUMENT, HITTING THE TIP AGAINST OTHER INSTRUMENTS OR AGAINST STERILIZATION CONTAINERS CAN DAMAGE THE CERAMIC TIP AND 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 PROCEDURE, THE CERAMIC TIP OF THE ROTATING CF RESECTOSCOPE CAME OFF AND FELL INTO THE PT. THE TIP WAS RETRIEVED WITHOUT ANY PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING CF RESECTOSCOPE ROTATING RESECTOSCOPE FJL GYRUS ACMI, INC. ERIS-CF25

    Patients

    Seq Age Sex Outcome Treatment
    1