BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 3886186 · Received April 8, 2014

    Report

    Report Number
    2951238-2014-00168
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 28, 2014
    Manufacturer
    GYRUS ACMI INC.
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BE RETURNED TO OLYMPUS FOR EVAL. IF ADD'L INFO IS RECEIVED AT A LATER TIME THIS REPORT WILL BE SUPPLEMENTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE FOR A BLADDER TUMOR REMOVAL, THE TIP OF THE ERIS-CF25, ROTATING RESECTOSCOPE INNER SHEATH BROKE OFF. THE BROKEN PIECE WAS REMOVED FROM THE PT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212743 ROTATING CF RESECTOSCOPE INNER SHEATH ROTATING CF RESECTOSCOPE INNER SHEATH FJL GYRUS ACMI INC. ERIS-CF25 GS

    Patients

    Seq Age Sex Outcome Treatment
    1