BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 3886602 · Received April 15, 2014

    Report

    Report Number
    2951238-2014-00171
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 25, 2014
    Manufacturer
    GYRUS ACMI INC
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERENCED IN THIS REPORT HAS NOT BEEN 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 TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE, THE CERAMIC TIP OF THE DEVICE BROKE OFF AND FELL INSIDE THE PT. THE PHYSICIAN RETRIEVED THE BROKEN PIECE FROM THE PT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A DIFFERENT DEVICE. THERE WAS MODERATE BLEEDING REPORTED, BUT NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229462 ROTATING CF RESECTOSCOPE INNER SHEATH INNER SHEATH FJL GYRUS ACMI INC ERIS-CF25 BR

    Patients

    Seq Age Sex Outcome Treatment
    1