APEX
Received Mar 14, 2014 · Event occurred Feb 17, 2014
Report 9617016-2014-00006 · MDR key 3679052
Device
Generic name
Block, Beam-shaping, Radiation Therapy
Manufacturer
Elekta LtdProduct problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER QUESTIONS THE CLINICAL VALIDATION OF ELEKTA PRODUCTS WITH A THIRD PARTY FRAMELESS MASK SYSTEM (THIS RESTS UPON THE IBEAM EVO FRAMELESS EXTENSION). IBEAM EVO FRAMELESS HEAD AND NECK EXTENSION' HAS A MUCH LONGER SECTION (~168MM) WHICH IS THE SAME AS THE WIDTH OF THE IBEAM EVO AND THEREFORE REDUCING THE CLEARANCE. TO ENSURE CLEARANCE WITH THIS EXTENSION AND THE APEX, AGILITY AND XVI COMBINATION, THE CUSTOMER SUGGESTS THAT AT LATERAL: 0.0CM, THE COUCH LONGITUDINAL NEEDS TO BE APPROXIMATELY 5 ~ 7CM.THE CUSTOMER QUESTIONS THE CLINICAL VALIDATION OF ELEKTA PRODUCTS WITH A THIRD PARTY FRAMELESS MASK SYSTEM (THIS RESTS UPON THE IBEAM EVO FRAMELESS EXTENSION). IBEAM EVO FRAMELESS HEAD AND NECK EXTENSION' HAS A MUCH LONGER SECTION (~168MM) WHICH IS THE SAME AS THE WIDTH OF THE IBEAM EVO AND THEREFORE REDUCING THE CLEARANCE. TO ENSURE CLEARANCE WITH THIS EXTENSION AND THE APEX, AGILITY AND XVI COMBINATION, THE CUSTOMER SUGGESTS THAT AT LATERAL: 0.0CM, THE COUCH LONGITUDINAL NEEDS TO BE APPROXIMATELY 5 ~ 7CM.
Additional Manufacturer Narrative
THIS COMBINATION HAS NOT CURRENTLY BEEN VALIDATED. COLLISON RISK OF THE EQUIPMENT IS THE MOST LIKELY OUTCOME. NO PATIENT INJURIES HAVE BEEN REPORTED. THIS IS THE MANUFACTURER'S FINAL REPORT.