MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MONACO; SYSTEM, PLANNING, RADIATION THERAPY TREATMENT

Lot Number	6.2.3.0
Medical Device Problem Code	Application Program Problem: Dose Calculation Error (1189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
Internal testing found that when calculating a qa plan, segments are skipped in the calculation but remain in the plan.
Additional Manufacturer Narrative
G4 updated.H4 updated.H11 updated: internal testing found that when calculating a qa plan, segments are skipped in the calculation but remain in the plan.The investigation was completed by conducting a thorough evaluation of the products and the reported information.A defect was found internally during testing for dose discrepancies between vmat and collapsed dmlc plans.In monaco 6.2.3, when collapsing a vmat plan to a create a qa plan, for segments that are skipped in calculation but remain in the plan, an error condition is falsely detected.For example, if the patient plan is recalculated, some segments may be missing from the calculation and the calculated dose will be inconsistent with the plan.Investigation confirmed that this only happens on dmlc qa plans and those that are created from a vmat for qa.This problem only affects mlci2 plans.Mlci2 is end of life.It was also found that the defect only affects qa plans, which are not delivered to the patient.The clinical treatment plan is not affected by this defect.Testing found the root cause to be failure of error checking code, which should abandon the calculation.Instead, the calculation is not stopped, and the returned result excludes one or more segments.This defect is considered to be no risk - detectable before use.A discrepancy between the qa plan and clinical plan would likely be detected during the qa process.

• Brand Name: MONACO
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 22802614
• Report Number: 3015232217-2025-00049
• Device Sequence Number: 15691043
• Product Code: MUJ
• UDI-Device Identifier: 07340201500064
• UDI-Public: (01)07340201500064(10)6.2.3.0
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K223233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Lot Number: 6.2.3.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown