BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KARL STORZ ENDOSCOPY BIPOLAR COAGULATION BALL ELECTRODE

    MDR report key: 2061312 · Received April 12, 2011

    Report

    Report Number
    MW5020264
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 12, 2011
    Manufacturer
    KARL STORZ ENDOSCOPY AMERICA, INC.
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT TRANSURETHRAL RESECTION OF THE PROSTATE. DURING THE ABLATION PROCESS, THE ROLLERBALL METAL PIECE WAS NO LONGER VISUALIZED ATTACHED TO ITS TWO RODS. THE INSTRUMENT WAS REMOVED. TO PREVENT HARM, THE METALLIC PIECE WAS LEFT BEHIND. THE PT WAS DISCHARGED TO HOME AND RETURNED FOR A CYSTOSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KARL STORZ ENDOSCOPY BIPOLAR COAGULATION BALL ELECTRODE BIPOLAR COAGULATION BALL ELECTRODE GEI KARL STORZ ENDOSCOPY AMERICA, INC. 40331

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other