BEUDAMED
    FDA Adverse Event Other Summary report: N

    KARL STORZ

    MDR report key: 1882413 · Received October 22, 2010

    Report

    Report Number
    9610617-2010-00033
    Event Type
    Other
    Date Received
    October 22, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    KARL STORZ GMBH & CO., KG
    Product Code
    FJL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WORKING ELEMENT ELECTRICAL SADDLE HAD A BROKEN 9MM PIECE OF AN ELECTRODE STUCK IN LOCKING RECEPTACLE. THIS PREVENTED THE DOCTOR FROM INSERTING AND LOCKING THE ELECTRODE BEFORE THE CASE. THE SHAFT OF THE WORKING ELEMENT AND THE ELECTRODE CHANNEL ARE BENT AND DENTED, BUT ONCE THE BROKEN END OF ELECTRODE WAS REMOVED, ELECTRODE WAS ABLE TO BE LOCKED IN.

    Description of Event or Problem · 1

    ALLEGEDLY, AT THE START OF A TURBT CASE, THE DOCTOR WAS UNABLE TO LOCK THE ELECTRODE INTO THE EXTENDED LENGTH WORKING ELEMENT. HE SWITCHED TO STANDARD LENGTH TO CONDUCT AND COMPLETE PROCEDURE. HE WAS UNABLE TO REACH AND RESECT A TUMOR DUE TO ITS LOCATION; THE STANDARD LENGTH WOULD NOT REACH FAR ENOUGH. THE DOCTOR SAID HE WASN'T CERTAIN HE COULD HAVE REACHED TUMOR WITH THE EXTENDED LENGTH EITHER DUE TO ITS LOCATION. DOCTOR HAS NO PLANS TO RESCHEDULE DUE TO PATIENT'S HEALTH CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ EXTENDED LENGTH WORKING ELEMENT FJL KARL STORZ GMBH & CO., KG 27050EP KD

    Patients

    Seq Age Sex Outcome Treatment
    1 Other