RAYSTATION
Report
- Report Number
- 3010034862-2022-00001
- Event Type
- Injury
- Date Received
- May 3, 2022
- Date of Event
- March 22, 2022
- Report Date
- April 3, 2025
- Manufacturer
- RAYSEARCH LABORATORIES AB (PUBL)
- Product Code
- MUJ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
UNLIKE THE REMOVE SMALL CONTOUR'S FUNCTION WHERE THERE IS A SIZE CONSTRAINT ON CONTOURS TO BE REMOVED WHEN TIDYING CONTOURS, THE REMOVE HOLE'S FUNCTION REMOVES HOLES OF ANY SIZE. THERE ARE OFTEN ROIS WHERE HOLES ARE INTENDED AND REQUIRED (E.G. LUNG - GTV, COUCH STRUCTURE, OTHER PLANNING STRUCTURES). IT IS TOO EASY TO UNINTENTIONALLY REMOVE THESE HOLES AND FOR THIS TO GO UNDETECTED WITH POTENTIAL TO CAUSE TREATMENT ERRORS. THIS WAS A USE ERROR IN THAT THE COUCH ROI WAS NOT PROPERLY REVIEWED, SINCE IT IS ALWAYS THE USER'S RESPONSIBILITY TO ENSURE THAT DELINEATED REGIONS ARE AS INTENDED BEFORE APPROVAL.
THE REMOVE HOLES FUNCTION WAS USED FROM A DIALOG WHERE SELECTED REGIONS OF INTEREST (ROI) WHERE DISPLAYED IN A LIST WITH A SCROLLBAR. THE ROI REPRESENTING THE COUCH WAS THE ACTIVE ROI WHEN OPENING THE DIALOG AND THEREFORE SELECTED AS DEFAULT IN THE DIALOG, BUT IT WAS NOT VISIBLE WITHOUT SCROLLING. THE USER SELECTED THE ROI FOR WHICH REMOVE HOLES WAS INTENDED, BUT DID NOT SEE THAT THE COUCH ROI WAS ALSO SELECTED. AS A RESULT, THE INTERIOR OPENING OF THE COUCH ROI WAS REMOVED. THE INCORRECT COUCH ROI WAS NOT PROPERLY REVIEWED BEFORE APPROVAL AND WAS USED DURING PLANNING AND DOSE CALCULATION. AS PLAN QA WAS PERFORMED WITHOUT THE COUCH, THE DOSE DEVIATION WAS NOT DETECTED. PATIENT WAS TREATED WITH APPROXIMATELY 5% MORE DOSE THAN INTENDED FOR ALL FRACTIONS. DEVICE FUNCTIONS AS DESIGNED, BUT USABILITY IMPROVEMENTS WILL BE MADE FOR FUTURE VERSIONS.
FOLLOW-UP OF REPORT RSA MDR: 3010034862-2022-00001 (B)(6) REMOVE HOLE FUNCTION. THE REMOVE HOLES FUNCTION WAS USED FROM A DIALOG WHERE SELECTED REGIONS OF INTEREST (ROI) WHERE DISPLAYED IN A LIST WITH A SCROLLBAR. THE ROI REPRESENTING THE COUCH WAS THE ACTIVE ROI WHEN OPENING THE DIALOG AND THEREFORE SELECTED AS DEFAULT IN THE DIALOG, BUT IT WAS NOT VISIBLE WITHOUT SCROLLING. THE USER SELECTED THE ROI FOR WHICH REMOVE HOLES WAS INTENDED, BUT DID NOT SEE THAT THE COUCH ROI WAS ALSO SELECTED. AS A RESULT, THE INTERIOR OPENING OF THE COUCH ROI WAS REMOVED. THE INCORRECT COUCH ROI WAS NOT PROPERLY REVIEWED BEFORE APPROVAL AND WAS USED DURING PLANNING AND DOSE CALCULATION. AS PLAN QA WAS PERFORMED WITHOUT THE COUCH, THE DOSE DEVIATION WAS NOT DETECTED. PATIENT WAS TREATED WITH ~5% MORE DOSE THAN INTENDED FOR ALL FRACTIONS. DEVICE FUNCTIONS AS DESIGNED, BUT USABILITY IMPROVEMENTS WILL BE MADE FOR FUTURE VERSIONS.
FOLLOW-UP OF REPORT RSA MDR: 3010034862-2022-00001 (B)(6) REMOVE HOLE FUNCTION. NO MALFUNCTION HAPPENED. USE ERROR. THE REMOVE HOLE'S FUNCTION WAS USED FROM A DIALOG WHERE SELECTED REGIONS OF INTEREST (ROI) WHERE DISPLAYED IN A LIST WITH A SCROLLBAR. THE ROI REPRESENTING THE COUCH WAS THE ACTIVE ROI WHEN OPENING THE DIALOG AND THEREFORE SELECTED AS DEFAULT IN THE DIALOG, BUT IT WAS NOT VISIBLE WITHOUT SCROLLING. THE USER SELECTED THE ROI FOR WHICH REMOVE HOLES WAS INTENDED, BUT DID NOT SEE THAT THE COUCH ROI WAS ALSO SELECTED. AS A RESULT, THE INTERIOR OPENING OF THE COUCH ROI WAS REMOVED. THE INCORRECT COUCH ROI WAS NOT PROPERLY REVIEWED BEFORE APPROVAL AND WAS USED DURING PLANNING AND DOSE CALCULATION. AS PLAN QA WAS PERFORMED WITHOUT THE COUCH, THE DOSE DEVIATION WAS NOT DETECTED. PATIENT WAS TREATED WITH ~5% MORE DOSE THAN INTENDED FOR ALL FRACTIONS. DEVICE FUNCTIONS AS DESIGNED, BUT USABILITY IMPROVEMENTS WILL BE MADE FOR FUTURE VERSIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2074682 | RAYSTATION | RADIATION THERAPY TREATMENT PLANNING SYSTEM | MUJ | RAYSEARCH LABORATORIES AB (PUBL) | RAYSTATION 10B |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |