BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPOLAR WORKING ELEMENT

    MDR report key: 2211438 · Received August 9, 2011

    Report

    Report Number
    9611102-2011-00001
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 9, 2011
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL SENT ONLY THE WORKING ELEMENT (B)(4) WHICH IS A COMPONENT OF THE BIPOLAR RESECTOSCOPE SET. AS WE WANT TO PERFORM A FULL INVESTIGATION AND WE WANT TO RECONSTRUCT THE OCCURRENCE, WE NEED FURTHER COMPONENTS FROM THE RESECTOSCOPE SET. THEREFORE, WE ASK THE HOSPITAL TO SEND THE RESECTOSCOPE SHEATH AND THE ELECTRODE THAT WERE IN USE DURING APPLICATION TO RICHARD WOLF. AFTER WE HAVE COMPLETED OUR INVESTIGATIONS, WE WILL SEND A F/U.

    Description of Event or Problem · 1

    DURING A BIPOLAR RESECTION, THE URETHRA OF THE PT HAS BEEN BURNED. THE SURGEON USED THE BIPOLAR RESECTION SET FROM RICHARD WOLF. FURTHER INFO IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPOLAR WORKING ELEMENT BIPOLAR WORKING ELEMENT GEI RICHARD WOLF GMBH 8680.225 M890870

    Patients

    Seq Age Sex Outcome Treatment
    1 Other