APEX
Received Nov 22, 2012 · Event occurred Oct 22, 2012
Report 9617016-2012-00007 · MDR key 5666158
Device
Generic name
Block, Beam-shaping, Radiation Therapy
Manufacturer
Elekta Ltd.Product problems
- Break
- Detachment of Device or Device Component
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
FROM THE RESULTS OF THE INVESTIGATION, APEX (COLLIMATION HEAD) 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
WHILE PERFORMING TEST ON APEX THE SYSTEM BECAME DETACHED FROM THE LINAC HEAD DURING GANTRY ROTATION. THERE HAS BEEN NO INJURY AS A CONSEQUENCE OF THE INCIDENT, BUT SIGNIFICANT DAMAGE WAS SUSTAINED TO THE EQUIPMENT.