RAYSTATION
Report
- Report Number
- 3010034862-2022-00003
- Event Type
- Injury
- Date Received
- August 4, 2022
- Date of Event
- July 18, 2022
- Report Date
- April 4, 2025
- Manufacturer
- RAYSEARCH LABORATORIES AB (PUBL)
- Product Code
- MUJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THERE WAS NO MALFUNCTION. THERE WILL ALWAYS BE SOME RISK OF USE ERRORS WITH COMPLEX SYSTEMS. IN THIS CASE, THE RISK IS LOW AND ACCEPTABLE, AND IT IS USER'S RESPONSIBILITY TO VERIFY ANY MATERIAL OVERRIDES USED.
A RAYSTATION CUSTOMER HAS REPORTED A MISTREATMENT FOR ONE PATIENT. WHEN CREATING THE PATIENT MODEL FOR A BREAST PATIENT WITH A SILICONE IMPLANT, THE PLANNER CREATED A MATERIAL OVERRIDE STRUCTURE AND SELECTED "SILICON" AS MATERIAL. THE CORRECT DENSITY OF THE SILICONE POLYMER USED IN THE IMPLANT IS CLOSE TO WATER (~.94-.98). THE PURE SILICON IN THE MATERIAL LIST HAS A DENSITY OF 2.33. THE PATIENT WAS INTENDED TO BE TREATED WITH PROTONS. LUCKILY, THE PROTON SYSTEM WAS DOWN FOR SEVERAL DAYS, AND THE PATIENT WAS MOVED TO PHOTON TREATMENT FOR WHICH DENSITY HAS LESS IMPACT ON DOSE. WHEN THEY MOVED BACK TO THE PROTON MACHINE, THE ERROR WAS NOTED. THIS CLINIC'S INVESTIGATION DEEMED IT NOT TO BE A MISADMINISTRATION DUE TO THE FACT THAT THE PTV RECEIVED PROPER DOSE. HOWEVER, IF THE MISTAKE WERE TO RECUR FOR PROTON TREATMENT, THERE COULD BE SIGNIFICANT DOSE DEVIATIONS SO THE EVENT IS CONSIDERED REPORTABLE BY THE MANUFACTURER. THERE WAS NO MALFUNCTION. MISTREATMENT WAS CAUSED BY A USER MISTAKE, CONFUSING SILICON, SI, WITH SILICONE POLYMER. DENSITY IS DISPLAYED WITH THE MATERIAL NAMES, SO ALL INFORMATION NEEDED FOR CORRECT MATERIAL ASSIGNMENT IS AVAILABLE IN THE UI. HOWEVER, USER INTERFACE IMPROVEMENTS WILL STILL BE CONSIDERED FOR FUTURE RAYSTATION VERSIONS.
FOLLOW-UP OF REPORT RSA MDR: 3010034862-2022-00003 (B)(6) MATERIAL OVERRIDE SILICONE. A RAYSTATION CUSTOMER HAS REPORTED A MISTREATMENT FOR ONE PATIENT. WHEN CREATING THE PATIENT MODEL FOR A BREAST PATIENT WITH A SILICONE IMPLANT, THE PLANNER CREATED A MATERIAL OVERRIDE STRUCTURE AND SELECTED "SILICON" AS MATERIAL. THE CORRECT DENSITY OF THE SILICONE POLYMER USED IN THE IMPLANT IS CLOSE TO WATER (~.94-.98). THE PURE SILICON IN THE MATERIAL LIST HAS A DENSITY OF 2.33. THE PATIENT WAS INTENDED TO BE TREATED WITH PROTONS. LUCKILY, THE PROTON SYSTEM WAS DOWN FOR SEVERAL DAYS, AND THE PATIENT WAS MOVED TO PHOTON TREATMENT FOR WHICH DENSITY HAS LESS IMPACT ON DOSE. WHEN THEY MOVED BACK TO THE PROTON MACHINE, THE ERROR WAS NOTED. THIS CLINIC'S INVESTIGATION DEEMED IT NOT TO BE A MISADMINISTRATION DUE TO THE FACT THAT THE PTV RECEIVED PROPER DOSE. HOWEVER, IF THE MISTAKE WERE TO RECUR FOR PROTON TREATMENT, THERE COULD BE SIGNIFICANT DOSE DEVIATIONS SO THE EVENT IS CONSIDERED REPORTABLE BY THE MANUFACTURER. THERE WAS NO MALFUNCTION. MISTREATMENT WAS CAUSED BY A USER MISTAKE, CONFUSING SILICON, SI, WITH SILICONE POLYMER. DENSITY IS DISPLAYED WITH THE MATERIAL NAMES, SO ALL INFORMATION NEEDED FOR CORRECT MATERIAL ASSIGNMENT IS AVAILABLE IN THE UI. HOWEVER, USER INTERFACE IMPROVEMENTS WILL STILL BE CONSIDERED FOR FUTURE RAYSTATION VERSIONS.
FOLLOW-UP OF REPORT RSA MDR: 3010034862-2022-00003 (B)(6) MATERIAL OVERRIDE SILICONE. A RAYSTATION 10B CUSTOMER IN THE US HAS REPORTED A MISTREATMENT FOR ONE PATIENT. FOR A BREAST CASE WHERE THE PATIENT HAD A SILICONE IMPLANT, THE PLANNER CREATED A MATERIAL OVERRIDE STRUCTURE AND SELECTED "SILICON" AS MATERIAL. THE CORRECT DENSITY OF THE SILICONE POLYMER USED IN THE IMPLANT IS CLOSE TO WATER (~.94-.98). THE PURE SILICON THAT IS PRE-CONFIGURED IN THE MATERIAL LIST THAT HAS A DENSITY OF 2.33. THE PATIENT WAS INTENDED TO BE TREATED WITH PROTONS. LUCKILY, THE PROTON SYSTEM WAS DOWN FOR SEVERAL DAYS, AND THE PATIENT WAS MOVED TO PHOTONS. WHEN THEY MOVED BACK TO THE PROTON MACHINE, THE ERROR WAS NOTED. THIS WAS A MISTREATMENT, BUT THE CLINIC INVESTIGATED IT AND DEEMED IT NOT TO BE A MISADMINISTRATION DUE TO THE FACT THAT THE PTV RECEIVED PROPER DOSE. HOWEVER, IF THE MISTAKE WERE TO RECUR FOR PROTON TREATMENT, THERE COULD BE SIGNIFICANT DOSE DEVIATIONS SO THE EVENT IS CONSIDERED REPORTABLE BY THE MANUFACTURER. THERE WAS NO MALFUNCTION. MISTREATMENT WAS CAUSED BY A USER MISTAKE, CONFUSING SILICON, SI, WITH SILICONE POLYMER. DENSITY IS DISPLAYED WITH THE MATERIAL NAMES, SO ALL INFORMATION NEEDED FOR CORRECT MATERIAL ASSIGNMENT IS AVAILABLE IN THE UI. HOWEVER, USER INTERFACE IMPROVEMENTS WILL STILL BE CONSIDERED FOR FUTURE RAYSTATION VERSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2390076 | RAYSTATION | RADIATION THERAPY TREATMENT PLANNING SYSTEM | MUJ | RAYSEARCH LABORATORIES AB (PUBL) | RAYSTATION 11A SP2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |