BEUDAMED
    FDA Adverse Event Summary report: N

    OLYMPUS HF-RESECTION ELECTRODE

    MDR report key: 3890027 · Received April 21, 2014

    Report

    Report Number
    3890027
    Date Received
    April 21, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 21, 2014
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FJL
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR A TRANSURETHRAL RESECTION OF THE PROSTATE WITH REMOVAL OF BLADDER STONES. THE PHYSICIAN WAS REMOVING THE BLADDER STONE WITH THE RESECTOR WHEN THE TIP OF IT BROKE OFF INTO THE BLADDER. IT IS MEANT TO SHAVE THE SOFT TISSUE BUT THE PHYSICIAN WAS USING IT TO BRING THE STONE FORWARD AND BENT THE LOOP. DUE TO THE LOOP BEING BENT THE PHYSICIAN TWISTED AND TURNED IT UNTIL HE COULD PULL IT BACK OUT AND A VERY SMALL PIECE, ABOUT THE SIZE OF THE TIP OF A PEN, BROKE OFF THE LOOP. AN X-RAY WAS TAKEN TO SEE IF THERE WAS ANY REMNANTS OF THE TIP IN THE BLADDER AND NONE WERE FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241941 OLYMPUS HF-RESECTION ELECTRODE ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL FJL OLYMPUS WINTER & IBE GMBH * 14009P02L001

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR NO OTHER THERAPIES