BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC-CX

    MDR report key: 23040289 · Received September 12, 2025

    Report

    Report Number
    2916710-2025-00001
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    August 15, 2025
    Report Date
    September 19, 2025
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    UDI-DI
    00858086006405
    PMA / PMN Number
    K181404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER NARRATIVE HAS BEEN UPDATED TO REFLECT THE ACCURATE INVESTIGATION SUMMARY; NO OTHER CHANGES WERE MADE. THE CUSTOMER REPORTED THAT AFTER APPLYING THE FIRST FIELD, THE COUCH AND GANTRY WERE MOVED (BY THE OPERATOR VIA DEDICATED KEYBOARD (DKB)) TO THE SECOND FIELD POSITION. DURING THIS MOVEMENT THE GANTRY COLLIDED WITH THE PATIENT ON THE COUCH LEADING TO SEVERE HEAD INJURIES. THE PATIENT HAD PREVIOUSLY COMPLETED SIMULATION SUCCESSFULLY WITHOUT INCIDENT. HOWEVER, DURING THE FIRST TREATMENT SESSION, THE THERAPIST LIKELY DID NOT PAY ATTENTION TO THE VIDEO MONITORING SYSTEM WHILE POSITIONING THE GANTRY AND TREATMENT TABLE. AS A RESULT, THE GANTRY CONTACTED THE PATIENT. THE INCIDENT WAS CAUSED BY USER ERROR AND INATTENTION WHILE SETTING UP THE PATIENT FOR TREATMENT. THERE WAS NO FAILURE OF VARIAN SOFTWARE OR HARDWARE. VARIAN HAS IMPLEMENTED ZONE RULES TO HELP REDUCE THE RISK OF COLLISIONS BETWEEN THE GANTRY, TREATMENT TABLE, AND PATIENT DURING STANDARD CLINICAL SETUPS. HOWEVER, AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU) DOCUMENT (B)(4) ¿CLINIC INSTRUCTIONS FOR USE¿ PAGES 45-46 AND 56-68, ZONE RULES HAVE LIMITATIONS, PARTICULARLY IN SCENARIOS INVOLVING ATYPICAL ORIENTATIONS OF THE GANTRY, PATIENT, OR TABLE.¿ IN SUCH CASES, USERS ARE ADVISED TO EXERCISE INCREASED CAUTION TO PREVENT POTENTIAL COLLISIONS. THE IFU DESCRIBES HOW EXCLUSION ZONES WORK, WHAT THEY CAN AND WHAT THEY CAN'T DO AND MOST IMPORTANTLY HOW TO AVOID COLLISIONS (P.56 ¿PREVENT COLLISIONS DURING REMOTE MOTIONS.) IN ADDITION, VARIAN RECOMMENDS PERFORMING A DRY-RUN TO CHECK FOR POTENTIAL COLLISIONS ESPECIALLY PRIOR TO THE FIRST TREATMENT (IFU, P.56).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT AFTER APPLYING THE FIRST FIELD, THE COUCH AND GANTRY WERE MOVED (BY THE OPERATOR VIA DEDICATED KEYBOARD (DKB)) TO THE SECOND FIELD POSITION. DURING THIS MOVEMENT THE GANTRY COLLIDED WITH THE PATIENT ON THE COUCH LEADING TO SEVERE HEAD INJURIES. THE PATIENT HAD PREVIOUSLY COMPLETED SIMULATION SUCCESSFULLY WITHOUT INCIDENT. HOWEVER, DURING THE FIRST TREATMENT SESSION, THE THERAPIST DID NOT MONITOR THE VIDEO SYSTEM WHILE POSITIONING THE GANTRY AND TREATMENT TABLE. AS A RESULT, IT CONTACTED THE PATIENT. THE INCIDENT WAS CAUSED BY USER ERROR AND INATTENTION WHILE SETTING UP THE PATIENT FOR TREATMENT. THERE WAS NO FAILURE OF VARIAN SOFTWARE OR HARDWARE. VARIAN HAS IMPLEMENTED ZONE RULES TO HELP REDUCE THE RISK OF COLLISIONS BETWEEN THE GANTRY, TREATMENT TABLE, AND PATIENT DURING STANDARD CLINICAL SETUPS. HOWEVER, AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU) (B)(4) ¿CLINAC INSTRUCTIONS FOR USE¿ PAGES 45-46 AND 56-68, ZONE RULES HAVE LIMITATIONS, PARTICULARLY IN SCENARIOS INVOLVING ATYPICAL ORIENTATIONS OF THE GANTRY, PATIENT, OR TABLE.¿ IN SUCH CASES, USERS ARE ADVISED TO EXERCISE INCREASED CAUTION TO PREVENT POTENTIAL COLLISIONS. THE IFU DESCRIBES HOW EXCLUSION ZONES WORK, WHAT THEY CAN AND WHAT THEY CAN'T AND MOST IMPORTANTLY HOW TO AVOID COLLISIONS (P.56 ¿PREVENT COLLISIONS DURING REMOTE MOTIONS. IN ADDITION, VARIAN RECOMMENDS PERFORMING A DRY-RUN TO CHECK FOR POTENTIAL COLLISIONS ESPECIALLY PRIOR TO THE FIRST TREATMENT (IFU, P.56). A DESIGN IMPROVEMENT WAS INTRODUCED TO BROADEN SUPPORT FOR NON-STANDARD CLINICAL SETUPS AND TO REDUCE THE RELIANCE ON EXCLUSION RULES.

    Description of Event or Problem · 0

    SEE COMPLETED (B)(4), MFR REPORT NUMBER (B)(4).

    Description of Event or Problem · 0

    DATE:(B)(6) 2025 TIME: MORNING (10:50-11:00) EVENT: COLLISION BETWEEN THE ACCELERATOR GANTRY AND THE PATIENT DURING TREATMENT. THE CUSTOMER REPORTED THAT AFTER APPLYING THE FIRST FIELD, THE COUCH AND GANTRY WERE MOVED (BY THE OPERATOR VIA DEDICATED KEYBOARD (DKB)) TO THE SECOND FIELD POSITION. DURING THIS MOVEMENT THE GANTRY COLLIDED WITH THE PATIENT ON THE COUCH LEADING TO SEVERE HEAD INJURIES. THE TECHNICIAN PRESSED THE CONSOLE MOVEMENT ENABLE BUTTON, LIKELY WITHOUT PAYING DUE ATTENTION TO THE VIDEO SYSTEM, CAUSING THE GANTRY AND COLLIMATOR TO ROTATE TO THE PLANNED 140° GANTRY AND 30° COLLIMATOR POSITION, BEFORE ADJUSTING THE TREATMENT TABLE, WHICH SHOULD HAVE BEEN REPOSITIONED TO 0°. DURING THIS MOMENT, THE GANTRY COLLIDED WITH THE PATIENT (IN THE HEAD REGION). UPON NOTICING THE ACCIDENT, THE TECHNICIANS PERFORMED THE EMERGENCY PROCEDURE BY LOWERING THE TABLE VERTICALLY BY ACTIVATING THE MANUAL LEVER, REMOVING THE PATIENT FROM THE TABLE, AND THEN CALLING THE NURSING STAFF AND THE RADIATION ONCOLOGIST, WHO PROVIDED FIRST AID WHILE STILL IN THE BUNKER. THE PATIENT DEVELOPED NASAL, EAR, AND MOUTH BLEEDING DUE TO THE COMPRESSION OF THE GANTRY ON HIS HEAD AND WAS ADMITTED TO THE HOSPITAL'S ICU. A CRANIAL CT SCAN REVEALED TRAUMATIC SUBARACHNOID HEMORRHAGE, AND FRACTURES OF THE LEFT TEMPORAL, SPHENOID, AND MASTOID BONES ON THE RIGHT. THE PATIENT ALSO PRESENTED TRAUMATIC PERIPHERAL NERVE INJURY (RIGHT FACIAL NERVE). THE PATIENT IS CURRENTLY STABLE, ALERT, CONSCIOUS, AND ORIENTED. PATIENT WAS DISCHARGED FROM THE ICU. THE SITE ALREADY RE-RAN THE SIMULATION (CT) TO RESUME HIS TREATMENT NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975142 CLINAC-CX LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS HCX6632 00858086006405

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Hospitalization