BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINAC

    MDR report key: 562266 · Received May 13, 2004

    Report

    Report Number
    2914292-2004-00006
    Event Type
    Other
    Date Received
    May 13, 2004
    Date of Event
    April 16, 2004
    Report Date
    May 13, 2004
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    IYE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INCIDENT AS PER COMMUNICATION WITH (MEDICAL CENTER REPRESENTATIVES: SUBSEQUENT TO PT THERAPY TREATMENT. TABLE WAS AT 90, THERAPIST OUTSIDE TREATMENT ROOM WAS ROTATING GANTRY. DURING ROTATION, THE THERAPIST WAS DISTRACTED BY ANOTHER PT IN WAITING ROOM, WHOM HAD COME UP TO ASK HER A QUESTION. A SECOND THERAPIST WAS ENTERING ROOM AS THE GANTRY WAS COMING INTO CONTACT WITH THE PT. GANTRY ROTATION WAS STOPPED AND REVERSED FROM PT POINT OF CONTACT. GANTRY CONTACTED PATIENTS PELVIS, RESULTING IN A HAIRLINE FRACTURE OF THE SYMPHYSIS PUBIS, AS DIAGNOSED BY PHYSICIAN USING SIMPLE X-RAY FILM. PT NOT HOSPITALIZED. PT HAD MOBILITY SUBSEQUENT TO INCIDENT, BUT EXPERIENCED PAIN. PT WAS TREATED IN THE ER AND SUBSEQUENTLY RELEASED. NO SURGICAL INTERVENTION REQUIRED. HOSPITALS SUBMITTED A VOLUNTARY REPORT TO THE FDA, 04/2004. THIS INCIDENT HAS BEEN RECOGNIZED BY THE INVOLVED THERAPIST/STAFF, HOSPITAL, AND VARIAN MEDICAL SYSTEMS, AS ENTIRELY "OPERATER ERROR".

    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 47 YR Other