BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE SIMULATOR

    MDR report key: 974759 · Received December 14, 2007

    Report

    Report Number
    9617016-2007-00030
    Event Type
    Injury
    Date Received
    December 14, 2007
    Date of Event
    May 30, 2007
    Report Date
    November 29, 2007
    Manufacturer
    ELEKTA LTD.
    Product Code
    IYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, ELEKTA, INC. WAS NOT DIRECTLY NOTIFIED OF THIS ADVERSE EVENT BY THE FACILITY. ELEKTA, INC REC'D A COPY OF THE USER MEDWATCH REPORT ON NOV. 19, 2007 FROM FDA AS OFFICIAL NOTIFICATION. COMMENTS: THE HOSP STATES THAT THE PT WAS NOT HARMED AS A RESULT OF THIS EVENT, RATHER THAT HER CONDITION IMPROVED. AFTER THE EVENT , PT WAS TREATED IN RIGHT MAINSTEM BRONCHUS. THERE WAS NO DOCUMENTED EQUIPMENT MALFUNCTION PROVIDED BY THE HOSP. IT APPEARS LIKELY THAT THE "REVERSE" BUTTON PRESENT ON THE CONSOLE FOR THE PRECISE SIMULATOR (USED TO REVERSE IMAGES) WAS INADVERTENTLY PRESSED PRIOR TO THE START OF PT TREATMENT, RESULTING IN A REVERSAL OF THE IMAGE WITH RESULTING INCORRECT TREATMENT TO THE UNDESIRED LOCATION. THIS CONCLUSION IS BASED ON THE FOLLOWING: HOSP PROVIDED A LETTER, DATED OCT. 27, 2007, TO ELEKTA REQUESTING EITHER AN ELECTRONIC DISABLING OF THE "REVERSE" BUTTON ON THE CONTROL CONSOLE OR A PHYSICAL BARRIER WHICH WOULD PREVENT THE BUTTON FROM BEING INADVERTENTLY PRESSED. PER HOSP REQUEST, ON OCT. 17, THE "REVERSE" BUTTON ON THE PRECISE SIMULATOR WAS ELECTRONICALLY DISABLED AND ON NOV 12 THE "REVERSE" BUTTON WAS PHYSICALLY REMOVED FROM THE PHILIPS SIMULATOR. THE "REVERSE" BUTTONS ON BOTH SIMULATORS (PRESENT FOR OVER 10 YEARS) WERE IN ACCEPTABLE OPERATIONAL CONDITION WITH NO FAILURES DETECTED. BOTH SIMULATORS STILL HAVE THE MANUAL CAPABILITY WITHIN THE SOFTWARE TO "INVERT/REVERSE" IMAGES IF NEEDED. WITH NO EQUIPMENT MALFUNCTION, INACCURATE QA CHECKS NOT DETECTING REVERSED IMAGES, THIS IS CONSIDERED A "USER ERROR".

    Description of Event or Problem · 1

    PT WITH INCURABLE LUNG CANCER HAD PLANNED IRRADIATION TREATMENT TO THE RIGHT MAINSTEM BRONCHUS, THE SUBCRANIAL LYMPH NODE REGION AND A PORTION OF THE MEDIASTINUM. THE PHYSICIANS DID NOT INTEND ON ENCOMPASSING ALL THE MEDIASTINAL DISEASE. A PLANNING SIMULATION UNDER FLUOROSCOPY WAS PERFORMED BY THE RESIDENT WHERE IMAGES WERE APPROVED. THE RADIATION BEAM WAS PLACED ON BOTH THE MEDIASTINUM AND SUBCRANIAL LYMPH NODES AS PLANNED. HOWEVER, IN ERROR, THE LEFT MAINSTEM BRONCHUS WAS INCLUDED INSTEAD OF THE RIGHT. THE X-RAY FILMS WERE REVIEWED BY THE ATTENDING RADIATION ONCOLOGIST. THE ENTIRE PLAN WAS LATER REVIEWED BY PLANNING SPECIALISTS IN DOSIMETRY AND OTHER PHYSICIANS AT ROUTINE CHART REVIEW. ALL OF THESE EFFORTS FAILED TO DETECT THE ERROR OF "LEFT MAINSTEM BRONCHUS INSTEAD OF RIGHT." A RADIATION THERAPY STUDENT WAS REVIEWING THE CHART AND NOTICED THE DISCREPANCY BETWEEN THE INTENDED AREA AND THE TREATED AREA. AFTER DETECTION, TREATMENT WAS IMMEDIATELY DISCONTINUED AT A TOTAL DOSE OF 2500 CGY (AT 250 CGY PER DAY) AFTER COMPLETING 10 OF 14 PLANNED TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE SIMULATOR ACCELERATOR, LINEAR, MEDICAL IYE ELEKTA LTD. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *