PROTEUSPLUS
Report
- Report Number
- 3000256071-2023-00002
- Event Type
- Malfunction
- Date Received
- May 3, 2023
- Date of Event
- December 2, 2022
- Report Date
- July 31, 2023
- Manufacturer
- IIBA (ION BEAM APPLICATIONS)
- Product Code
- LHN
- PMA / PMN Number
- K163500
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EZ
- Reporter Occupation
- 003
Narratives
IBA REFERENCE: (B)(4). DESCRIPTION OF THE EVENT: ON (B)(6) 2022, THE CUSTOMER REQUESTED IBA TEAM ON SITE TO IMPROVE THE ACCURACY OF THEIR PATIENT POSITIONING SYSTEM (PPS) IN THE TREATMENT ROOM 4. ON THE SAME DAY, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE AND THE MEASUREMENTS SHOWED AN ERROR IN THE POSITION OF THE PPS OF 1,6 MM. HOWEVER, THIS PROCEDURE IS CARRIED OUT ON A SINGLE POINT OF THE TREATMENT VOLUME AND DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME. THEREFORE, IBA IS REPORTING THIS EVENT PREVENTIVELY. THE PPS OF THE TREATMENT ROOM 4 HAS BEEN IMPACTED BY SMALL COLLISIONS SINCE ITS INSTALLATION. THESE COLLISIONS MAY BE THE ROOT CAUSE OF THE MEASURED ERROR. IMPACT OF THE EVENT: AN ERROR IN POSITION AT THE PPS LEVEL WILL BE IDENTIFIED IF THE USER ACQUIRES X-RAY IMAGES AFTER APPLYING THE CORRECTION VECTOR AS RECOMMENDED IN THE PROTEUS 235 - CLINICAL USER GUIDE. THIS MITIGATION CANNOT BE CONSIDERED EFFECTIVE IN ALL CASES AS, DEPENDING ON THE TREATMENT PLAN, MECHANICAL INTERFERENCES BETWEEN THE PPS AND THE FLAT PANELS MAY PREVENT THE ACQUISITION OF X-RAY IMAGES FOR SOME POSITIONS OF THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE IS A RISK OF A NON-DETECTED ERROR IN POSITION UP TO 5 MM FOR POSITIONS WHERE IMAGING THE PATIENT WITH X-RAY IS NOT POSSIBLE BECAUSE OF THESE MECHANICAL INTERFERENCES. HOWEVER, THE ERROR WOULD VARY CONTINUOUSLY OVER THE TREATMENT VOLUME. THEREFORE, IBA CONSIDERS THAT THERE ARE CHANCES THAT, BY ACQUIRING X-RAY IMAGES ON OTHER POINTS OF THE TREATMENT VOLUME, THE USER WOULD BE ABLE TO DETECT INTERMEDIATE ERRORS BETWEEN 1 AND 5 MM. BASED ON THIS INFORMATION, IBA EVALUATES THE RISK OF MAJOR INJURY (MISTREATMENT DUE TO MISALIGNMENT UP TO 5 MM) AS POSSIBLE. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK.
IBA REFERENCE: (B)(4). DESCRIPTION OF THE EVENT: ON DECEMBER 02, 2022, THE CUSTOMER REQUESTED IBA TEAM ON SITE TO IMPROVE THE ACCURACY OF THEIR PATIENT POSITIONING SYSTEM (PPS) IN THE TREATMENT ROOM 4. ON THE SAME DAY, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE AND THE MEASUREMENTS SHOWED AN ERROR IN THE POSITION OF THE PPS OF 1.6 MM. HOWEVER, THIS PROCEDURE IS CARRIED OUT ON A SINGLE POINT OF THE TREATMENT VOLUME AND DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME. THEREFORE, IBA IS REPORTING THIS EVENT PREVENTIVELY. THE PPS OF THE TREATMENT ROOM 4 HAS BEEN IMPACTED BY SMALL COLLISIONS SINCE ITS INSTALLATION. THESE COLLISIONS MAY BE THE ROOT CAUSE OF THE MEASURED ERROR. IMPACT OF THE EVENT: AN ERROR IN POSITION AT THE PPS LEVEL WILL BE IDENTIFIED IF THE USER ACQUIRES X-RAY IMAGES AFTER APPLYING THE CORRECTION VECTOR AS RECOMMENDED IN THE PROTEUS 235 - CLINICAL USER GUIDE. THIS MITIGATION CANNOT BE CONSIDERED EFFECTIVE IN ALL CASES AS, DEPENDING ON THE TREATMENT PLAN, MECHANICAL INTERFERENCES BETWEEN THE PPS AND THE FLAT PANELS MAY PREVENT THE ACQUISITION OF X-RAY IMAGES FOR SOME POSITIONS OF THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE IS A RISK OF A NON-DETECTED ERROR IN POSITION UP TO 5 MM FOR POSITIONS WHERE IMAGING THE PATIENT WITH X-RAY IS NOT POSSIBLE BECAUSE OF THESE MECHANICAL INTERFERENCES. HOWEVER, THE ERROR WOULD VARY CONTINUOUSLY OVER THE TREATMENT VOLUME. THEREFORE, IBA CONSIDERS THAT THERE ARE CHANCES THAT, BY ACQUIRING X-RAY IMAGES ON OTHER POINTS OF THE TREATMENT VOLUME, THE USER WOULD BE ABLE TO DETECT INTERMEDIATE ERRORS BETWEEN 1 AND 5 MM. BASED ON THIS INFORMATION, IBA EVALUATES THE RISK OF MAJOR INJURY (MISTREATMENT DUE TO MISALIGNMENT UP TO 5 MM) AS POSSIBLE. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK. UPDATES ON JUNE 30, 2023: AN ANALYSIS WAS CONDUCTED ON THE ERRORS MEASURED IN SEVERAL PPS POSITIONS FOLLOWING COLLISIONS AFTER WHICH THE "REALISOOFFSET VALIDATION" PROCEDURE FAILED (ERROR IN PPS POSITION > 1MM). THESE RESULTS SHOWED THAT THERE IS A HIGH PROBABILITY THAT SEVERAL POINTS IN THE TREATMENT VOLUME ARE OUT OF TOLERANCE, POTENTIALLY WITH A HIGHER ERROR IN PPS POSITIONS THAN MEASURED WITH THE "REALISOOFFSET VALIDATION" PROCEDURE. HOWEVER, CONSIDERING ALL THE POINTS VERIFIED, THE WORST CASE WAS AN ERROR IN PPS POSITION OF 2.439 MM. THEREFORE, IBA CONCLUDED THAT THE RISK OF MAJOR INJURY PREVIOUSLY EVALUATED WAS OVERESTIMATED AND THAT THE ISSUE LEADS TO A RISK OF MINOR INJURY (POSSIBLE MISTREATMENT DUE TO MISALIGNMENT UP TO 2.5 MM). TO DATE, NO INJURY CAUSED BY THIS PROBLEM HAS BEEN REPORTED TO IBA.
IBA REFERENCE: (B)(4). DESCRIPTION OF THE EVENT: ON (B)(6) 2022, THE CUSTOMER REQUESTED IBA TEAM ON SITE TO IMPROVE THE ACCURACY OF THEIR PATIENT POSITIONING SYSTEM (PPS) IN THE TREATMENT ROOM 4. ON THE SAME DAY, IBA CARRIED OUT THE "REALISOOFFSET VALIDATION" PROCEDURE AND THE MEASUREMENTS SHOWED AN ERROR IN THE POSITION OF THE PPS OF 1.6 MM. HOWEVER, THIS PROCEDURE IS CARRIED OUT ON A SINGLE POINT OF THE TREATMENT VOLUME AND DOES NOT ENSURE THAT THERE ARE NO HIGHER ERRORS ON OTHER POINTS OF THE TREATMENT VOLUME. THEREFORE, IBA IS REPORTING THIS EVENT PREVENTIVELY. THE PPS OF THE TREATMENT ROOM 4 HAS BEEN IMPACTED BY SMALL COLLISIONS SINCE ITS INSTALLATION. THESE COLLISIONS MAY BE THE ROOT CAUSE OF THE MEASURED ERROR. IMPACT OF THE EVENT: AN ERROR IN POSITION AT THE PPS LEVEL WILL BE IDENTIFIED IF THE USER ACQUIRES X-RAY IMAGES AFTER APPLYING THE CORRECTION VECTOR AS RECOMMENDED IN THE PROTEUS 235 - CLINICAL USER GUIDE. THIS MITIGATION CANNOT BE CONSIDERED EFFECTIVE IN ALL CASES AS, DEPENDING ON THE TREATMENT PLAN, MECHANICAL INTERFERENCES BETWEEN THE PPS AND THE FLAT PANELS MAY PREVENT THE ACQUISITION OF X-RAY IMAGES FOR SOME POSITIONS OF THE TREATMENT VOLUME. IBA CONSIDERS THAT THERE IS A RISK OF A NON-DETECTED ERROR IN POSITION UP TO 5 MM FOR POSITIONS WHERE IMAGING THE PATIENT WITH X-RAY IS NOT POSSIBLE BECAUSE OF THESE MECHANICAL INTERFERENCES. HOWEVER, THE ERROR WOULD VARY CONTINUOUSLY OVER THE TREATMENT VOLUME. THEREFORE, IBA CONSIDERS THAT THERE ARE CHANCES THAT, BY ACQUIRING X-RAY IMAGES ON OTHER POINTS OF THE TREATMENT VOLUME, THE USER WOULD BE ABLE TO DETECT INTERMEDIATE ERRORS BETWEEN 1 AND 5 MM. BASED ON THIS INFORMATION, IBA EVALUATES THE RISK OF MAJOR INJURY (MISTREATMENT DUE TO MISALIGNMENT UP TO 5 MM) AS POSSIBLE. IBA RISK AND TECHNICAL EXPERTS ARE DEFINING A STRATEGY TO FURTHER QUANTIFY THE SAFETY RISK. UPDATES ON JUNE 30, 2023: AN ANALYSIS WAS CONDUCTED ON THE ERRORS MEASURED IN SEVERAL PPS POSITIONS FOLLOWING COLLISIONS AFTER WHICH THE "REALISOOFFSET VALIDATION" PROCEDURE FAILED (ERROR IN PPS POSITION > 1MM). THESE RESULTS SHOWED THAT THERE IS A HIGH PROBABILITY THAT SEVERAL POINTS IN THE TREATMENT VOLUME ARE OUT OF TOLERANCE, POTENTIALLY WITH A HIGHER ERROR IN PPS POSITIONS THAN MEASURED WITH THE "REALISOOFFSET VALIDATION" PROCEDURE. HOWEVER, CONSIDERING ALL THE POINTS VERIFIED, THE WORST CASE WAS AN ERROR IN PPS POSITION OF 2.439 MM. THEREFORE, IBA CONCLUDED THAT THE RISK OF MAJOR INJURY PREVIOUSLY EVALUATED WAS OVERESTIMATED AND THAT THE ISSUE LEADS TO A RISK OF MINOR INJURY (POSSIBLE MISTREATMENT DUE TO MISALIGNMENT UP TO 2.5 MM). TO DATE, NO INJURY CAUSED BY THIS PROBLEM HAS BEEN REPORTED TO IBA. UPDATES ON JULY 31, 2023 : THE PPS OF THE TREATMENT ROOM 4 HAS BEEN IMPACTED BY MULTIPLE COLLISIONS SINCE ITS INSTALLATION. NO PATIENT INJURY HAS BEEN REPORTED TO IBA AFTER A COLLISION THAT INVOLVED THE PPS AND POTENTIALLY IMPACTED THE PPS ACCURACY. IBA CARRIED OUT AN ANALYSIS OF PPS ABSOLUTE ACCURACY ERRORS COLLECTED ON THE WHOLE TREATMENT VOLUME AFTER SEVERAL PAST COLLISION EVENTS. THE RESULTS OF THE ANALYSIS SHOWED THAT, AFTER A COLLISION WITH THE PPS, THERE IS A HIGH PROBABILITY THAT SEVERAL POSITIONS OVER THE WHOLE TREATMENT VOLUME MAY EXCEED THE 1 MM ERROR THRESHOLD. FOR THE EVENT OF DECEMBER 02, 2022, IN PAT.114, THE "REALISOOFFSET VALIDATION" PROCEDURE FAILED (MAXIMUM ERROR MEASURED WAS 1.6 MM). HENCE, BASED ON THE IBA STUDY OF PAST COLLISION EVENTS, IBA EVALUATES THAT THE WORST CASE OF POSITION ERROR AFTER THIS EVENT IS 2.5 MM. THEREFORE, IBA CONCLUDES THAT THE RISK INITIALLY EVALUATED WAS OVERESTIMATED AND THERE IS NO RISK OF SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714951 | PROTEUSPLUS | PROTON THERAPY SYSTEM | LHN | IIBA (ION BEAM APPLICATIONS) | PROTEUS 235 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |