BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRAIGHT COLD KNIFE

    MDR report key: 2022544 · Received February 4, 2011

    Report

    Report Number
    2022544
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 5, 2011
    Report Date
    February 4, 2011
    Manufacturer
    STORZ KARL STORZ- ENDOSKOPE
    Product Code
    EZO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    WHILE THE SURGEON WAS CUTTING THROUGH SCAR TISSUE, THE TIP OF THE COLD KNIFE BROKE OFF INTO THE PT. (URETHRAL MEATUS HAD STENOSIS DUE TO SCAR TISSUE.) THE FOLLOWING IS FROM THE OPERATIVE REPORT: A 22 FRENCH CYSTOSCOPE WAS USED FOR VISUALIZATION. THE CYTOSCOPE WAS INTRODUCED WITH A FIVE FRENCH WHISTLE TIP CATHETER WHICH WAS ADVANCED THRU THE STRICTURE TO GUIDE THE SCOPE. WHILE THE SURGEON WAS CUTTING THRU "VERY TOUGH" SCAR TISSUE, THE COLD KNIFE TIP BROKE. THE CYSTOSCOPE AND KNIFE WERE WITHDRAWN. A NEW KNIFE WAS OPENED AND REINTRODUCED USING A FIVE FRENCH WHISTLE TIP CATHETER AS A GUIDE. THE BROKEN COLD KNIFE BLADE TIP WAS FOUND IN THE PROSTATIC URETHRA WHERE THE DOCTOR PUSHED IT INTO THE BLADDER AND REMOVED IT BY USING GRASPING FORCEPS. THERE WAS NO DAMAGE TO THE URETHRA FROM THE BROKEN BLADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRAIGHT COLD KNIFE COLD KNIFE EZO STORZ KARL STORZ- ENDOSKOPE 27069K 38506

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR