BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CONTINUOUS FLOW RESECT, INNER SHEATH

    MDR report key: 1649400 · Received March 31, 2010

    Report

    Report Number
    1519132-2010-00011
    Event Type
    Other
    Date Received
    March 31, 2010
    Date of Event
    December 21, 2009
    Report Date
    March 31, 2010
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    PREAMEND.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ORIGINAL RETURN OF THE INSTRUMENT WAS RECORDED UNDER COMPLAINT (B)(4). IN THAT INVESTIGATION THE VISUAL INSPECTION OF THE INSTRUMENT CONFIRMED THAT THE CERAMIC TIP HAD BEEN BROKEN OFF AT THE TUBE. A SMALL AMOUNT OF THE CERAMIC TIP REMAINED SECURELY GLUED INSIDE THE DISTAL END OF THE SHEATH TUBE, BUT THE REMAINDER OF THE CERAMIC TIP HAD NOT BEEN RETURNED TO GYRUS ACMI. MINOR DENTS WERE NOTED ALONG THE LENGTH OF THE STEEL TUBE. THE RELEASE BUTTON WAS ALSO BROKEN. THE INSTRUMENT WAS RETURNED TO GYRUS ACMI FOR REPAIR ON JAN 5, 2010. CONCLUSION: A SEARCH OF PRIOR INCIDENTS FOR THIS TYPE OF INSTRUMENT WAS PERFORMED WITH THE SAME OR SIMILAR VERBIAGE IN THE PROBLEM DESCRIPTION. THE DOCUMENT SEARCH REVEALS SEVERAL POTENTIAL ROOT CAUSES AS FOLLOWS: 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 OUTER CYSTO SHEATH. PLEASE NOTE THAT THIS MISHANDLING IS CAUTIONED AGAINST IN THE INSTRUCTIONS FOR USE MANUAL THAT IS SHIPPED WITH THE INSTRUMENT. DENTS FOUND ALONG THE STEEL TUBE ARE OFTEN INDICATIONS THAT THE AFOREMENTIONED EXCESSIVE LATERAL FORCE HAS OCCURRED. A SECOND POTENTIAL CAUSE OF THE BREAKING OF THE TIP CAN 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 CAN LEAD TO FAILURE DURING SUBSEQUENT HANDLING OR USE. DUE TO THE PRESENCE OF THE NUMEROUS DENTS ON THE TUBE AND THE FRACTURED STATE OF THE CERAMIC TIP, THE CAUSE OF THIS FAILURE IS DETERMINED TO BE MISHANDLING.

    Description of Event or Problem · 1

    A 26-FRENCH RESECTOSCOPE USED IN TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) ON (B)(6) 2009; PT RETURNED TO SURGERY ON (B)(6) 2010 FOR RESECTION OF TUMOR AND EXPLORATION OF PAINFUL LUMP TOWARDS END OF PENIS CAUSING DIFFICULTY IN VOIDING. DISCOVERED WHITE RING IN PROXIMAL URETHRA THAT APPEARED TO BE PLASTIC RING OF RESECTOSCOPE. LARGE PIECE REMOVED; SMALL PIECE FRACTURED OFF AND WASHED BACK INTO THE BLADDER. SMALL PIECE LATER WASHED OUT OF BLADDER WITH A SCOPE. THE TIP OF THE RESECTOSCOPE NOTED TO BE MISSING ON (B)(6) 2009, BUT STAFF DID NOT SUSPECT IT HAD BROKEN OFF WHILE IN USE WITH PT, SO NO REPORT WAS MADE AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTATING CONTINUOUS FLOW RESECT, INNER SHEATH RESECTOSCOPE INNER SHEATH FJL GYRUS ACMI, INC. ERIS-CF25

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention