BEUDAMED
    FDA Adverse Event Death Summary report: N

    URETEROSCOPE, 7 FR FLEXIBLE

    MDR report key: 24775 · Received August 3, 1995

    Report

    Report Number
    24775
    Event Type
    Death
    Date Received
    August 3, 1995
    Date of Event
    June 16, 1995
    Report Date
    July 31, 1995
    Manufacturer
    KARL STORZ
    Product Code
    FGB
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FLEXIBLE URETEROSCOPE/CHOLEDOCHOSCOPE USED FOR EXTRACTION OF 2 STONES IN RENAL PELVIS (PROCEDURE SCHEDULED AS URETEROSCOPY). SCOPE BROUGHT TO FACILITY ON DAY OF PROCEDURE AT REQUEST OF SURGEON. PT SUFFERED HYPERABSOPTION OF WATER AND SUBSEQUENTLY DIED. AT RISK MGMT REVIEW ON 7/28/95 IT WAS FELT THAT THE DIAMETER OF THE SCOPE INHIBITED ANY RETURN TO BLADDER OF IRRIGATING FLUIDS; THERE WERE QUESTIONS REGARDING THE SAFETY OF UTILIZING/MARKETING THIS SCOPE FOR PEDIATRIC URETERAL PROCEDURES. (CO'S REP WAS PRESENT IN OR DURING PRODCEDURE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URETEROSCOPE, 7 FR FLEXIBLE URETEROSCOPE FGB KARL STORZ LOANED EQUIPMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death