BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 5011100 · Received August 18, 2015

    Report

    Report Number
    2951238-2015-00364
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 24, 2015
    Report Date
    July 24, 2015
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    FJL
    PMA / PMN Number
    K0890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE REPORTED PHENOMENON WAS CONFIRMED. THE DEVICE WAS VISUALLY INSPECTED AND FOUND THAT THE INNER SHEATH ASSEMBLY HAS A BROKEN ISOLATION BEAK AT THE DISTAL TIP. HOWEVER, THE BROKEN ISOLATION TIP WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED PHENOMENON CAN BE ATTRIBUTED TO IMPACT DAMAGE OR EXCESSIVE FORCE BEING APPLIED TO THE DEVICE. THE INSTRUCTION FOR USE STATES THAT EXCESSIVE SQUEEZING FORCE ON HANDLES CAN LEAD TO FAILURE OF THE ISOLATION TIP.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A THERAPEUTIC TRANSURETHRAL RESECTION OF THE BLADDER (TURB) AND STENT INSERTION PROCEDURE, THE TIP OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN RETRIEVED THE BROKEN PIECE FROM THE PATIENT USING THE BIOPSY CUP FORCEPS. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITHOUT ANY COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546501 ROTATING CF RESECTOSCOPE INNER SHEATH ROTATING CONT. FLOW INNER SHEATH FJL GYRUS ACMI INC. ERIS-CF25 RXCT

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR