BEUDAMED
    FDA Adverse Event Other Summary report: N

    ROTATING CF RESECTOSCOPE INNER SHEATH

    MDR report key: 2434037 · Received January 23, 2012

    Report

    Report Number
    1519132-2012-00005
    Event Type
    Other
    Date Received
    January 23, 2012
    Date of Event
    December 30, 2011
    Report Date
    January 13, 2012
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    FJL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THE INSTRUMENT FINDS A PIECE OF THE CERAMIC TIP TO BE BROKEN OFF AND THE RELEASE BUTTON TO BE BROKEN ALSO. DAMAGE IS CONSISTENT WITH CUSTOMER MISUSE.

    Description of Event or Problem · 1

    DURING A TRANSURETHRAL RESECTION OF THE PROSTATE, WHILE USING THE RESECTOSCOPE, THE INNER SHEATH TIP BROKE OFF IN THE PT. THE TIP WAS REMOVED WITHOUT PROBLEMS. AFTER EXAMINING THE PROSTATE TISSUE SPECIMEN, NO OTHER TIP FRAGMENTS WERE FOUND. KIDNEY, URETER AND BLADDER X-RAY WAS TAKEN, NO FURTHER EXAMS OR PROCEDURES WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1