BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC

    MDR report key: 475608 · Received August 1, 2003

    Report

    Report Number
    2914292-2003-00007
    Event Type
    Injury
    Date Received
    August 1, 2003
    Date of Event
    June 24, 2003
    Report Date
    July 29, 2003
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    "DURING THE SET-UP OF THE THIRD TREATMENT FIELD, THE TABLE WAS ANGLED AT 90 DEGREES FROM THE PREVIOUS POSITION, THE GANTRY ARM WAS AT APPROXIMATELY 22 DEGREES AND THE COLLIMATOR WAS TO BE ROTATED. THESE THREE CHANGES WERE OCCURRING ALMOST SIMULTANEOUSLY UNDER OPERATOR CONTROL. THE GANTRY ANGULATION WENT TO APPROXIMATELY 38 DEGREES. AT THAT TIME THE PT ALERTED THE OPERATOR THAT THE GANTRY WAS PRESSING ON THEIR ABDOMEN. THE GANTRY WAS INSTANTLY REMOVED. THE PT COMPLAINED OF ABDOMINAL TENDERNESS AND WAS EVALUATED BY THE RADIATION THERAPY PHYSICIAN. THE PT WAS SENT TO RADIOLOGY FOR ULTRASOUND AND NON-CONTRAST CT OF ABDOMEN. THE PT WAS THEN SENT TO THE ER FOR EVALUATION. THE PT HAD A HISTORY OF URINARY RETENTION. CREATININE WAS 2.9. A FOLEY CATHETER WAS PLACED IN THE ER AND 2300CC OF URINE WAS REMOVED. AN IVP AND CYSTOURETHEROGRAM WERE PERFORMED. A BLADDER PERFORATION WAS REVEALED AND THE PT WENT TO THE OPERATING ROOM FOR BLADDER REPAIR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS, INC. 2100C *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R