MAUDE Adverse Event Report: RAYSEARCH LABORATORIES AB (PUBL) RAYSTATION; RADIATION THERAPY TREATMENT PLANNING SYSTEM

Model Number 10B

Device Problems Application Program Problem: Dose Calculation Error (1189); Inadequate User Interface (2958)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

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.

• Brand Name: RAYSTATION
• Type of Device: RADIATION THERAPY TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): RAYSEARCH LABORATORIES AB (PUBL); eugeniavaegen 18; stockholm, 11368 ; SW 11368
• Manufacturer Contact: david hedfors ; eugeniavaegen 18; stockholm, 11368 ; SW 11368
• MDR Report Key: 14269074
• MDR Text Key: 299481348
• Report Number: 3007774465-2022-00001
• Device Sequence Number: 1
• Product Code: MUJ
• UDI-Device Identifier: 07350002010310
• UDI-Public: 07350002010310
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K210645
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10B
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other