APEX
Received Nov 28, 2012 · Event occurred Nov 9, 2012
Report 9617016-2012-00008 · MDR key 5666143
Device
Generic name
Block, Beam-shaping, Radiation Therapy
Manufacturer
Elekta Ltd.Product problems
- Failure to Cycle
- Detachment of Device or Device Component
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
FROM THE RESULTS OF THE CORRECTIVE ACTION, APEX WAS INCORRECTLY FITTED ON TO THE HEAD OF THE LINAC. THE ROTATION OF THE GANTRY WAS PREVENTED BY AN INHIBIT, BUT THE USER DECIDED TO OVERRIDE THE INHIBIT AND ROTATE THE LINAC GANTRY. THE APEX DETACHED FROM THE HEAD AND HIT THE FLOOR.
Description of Event or Problem
THE CUSTOMER WAS PREPARING FOR A PATIENT. THEY THOUGHT APEX WAS SECURELY MOUNTED AND ATTEMPTED TO ROTATE THE GANTRY. THE SYSTEM HAD A TOUCH GUARD INHIBIT SO THE GANTRY WOULD NOT ROTATE. THEY CONTACTED THE ELEKTA SERVICE ENGINEER WHO TOLD THEM HE WOULD BE THERE IN 30 MINUTES. HOWEVER BECAUSE THEY WERE PERFORMING A 'DRY RUN' THEY OVERRODE THE TOUCH GUARD TO INHIBIT TO ROTATE THE GANTRY. AT THIS TIME THE ELEKTA ENGINEER ARRIVED ON SITE. THE GANTRY WAS AT 300 DEGREES. THE CUSTOMER THEN ROTATED THE GANTRY, AS IT PASSED 0 DEGREES ROTATION, THE APEX DISENGAGED FROM THE MLC AND FELL TO THE FLOOR.