| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ACUITY | SIMULATOR | VARIAN MEDICAL SYSTEMS | KPQ | H77-SIM | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2010-07-14 | 0 |
Patient 1
THE USER REPORTED THAT DURING TREATMENT PLANNING CREATION IN ACUITY, THE MULTI LEAF COLLIMATOR SHAPE FOR A BEAM CREATED USING THE COPY AND OPPOSE BEAM FUNCTION IS MIRRORED ON THE X-AXIS, INSTEAD OF THE Y-AXIS. NO SERIOUS INJURY TO THE PATIENT WAS REPORTED, AS THIS EVENT WAS OBSERVED BY THE USER DURING TREATMENT PLANNING, AND THE PLAN WAS NOT USED.
Patient 1
BASED ON THE REPORTED INFORMATION, VARIAN HAS BEEN ABLE TO CONFIRM THE USER'S ALLEGATION: FOLLOWING PLAN CREATION AT ACUITY, AN IMAGE IS ACQUIRED AND GRABBED TO CREATE A FIELD FROM PATIENT ANTERIOR TO POSTERIOR (E.G. AP FIELD, AP IMAGE). AN OUTLINE IS DRAWN ON THE ACQUIRED IMAGE BY THE PHYSICIAN, OUTLINING THE AREAS TO BE TREATED. THE MULTI LEAF COLLIMATOR IS ADDED AND FITTED TO THIS OUTLINE. IF THE USER CREATES AN OPPOSING FIELD (PA FIELD, PA IMAGE), THE MLC ARE NOT CORRECTLY OPPOSED (THE MLC ON THE PA FIELD ARE POSITIONED EXACTLY AS ON THE AP FIELD RATHER THAN IN A MIRRORED POSITION). IF THE USER DOES NOT NOTICE THE INCORRECT PLACEMENT OF THE MLC ON THE OPPOSED FIELD AND IF IT IS NOT CAUGHT DURING PLAN REVIEW OR APPROVAL FOR TREATMENT, THE PATIENT CAN BE TREATED WITH INCORRECTLY PLACED MLC ON THE OPPOSED FIELD. AN INTERNAL CORRECTIVE ACTION WAS INITIATED TO FURTHER EVALUATE ANY FUTURE DESIGN IMPROVEMENT. AS A RESULT, A FUTURE RELEASE OF THE ACUITY SOFTWARE WILL CONTAIN A CORRECTION. IN ORDER TO MITIGATE RECURRENCE OF THIS ISSUE FOR CURRENT ACUITY USERS, A CUSTOMER TECHNICAL BULLETIN (CTB) WILL BE PROVIDED TO FURTHER DESCRIBE THE BEHAVIOR AND INSTRUCT ON THE AVAILABLE WORKAROUND. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.