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

Lot Number	6.2.2.0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported incorrect patient data loaded in contouring.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H2 updated.H6 updated.H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported incorrect patient data loaded in contouring.The patient was removed from the table before the next patient (prostate treatment) was loaded.Following the mri it was realised that the data coming from monaco (treatment planning system) belonged to the previous cervix patient.Following the restart of the device the issue did not recur.The customer was concerned that there could be a potential for mistreatment if two similar patients with similar treatment sites had their treatment plans mixed.The case was investigated to the fullest extent possible with limited information available.The issue could not be reproduced and assessed as a usage problem.To minimise the risk of similar incidents in the future, it is the user's responsibility to review the contours and structures prior to treatment delivery.The likelihood that the location and size of anatomical structures will match across different patients is negligible and any mismatch would be detectable prior to use.

• 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: 21918076
• Report Number: 3015232217-2025-00009
• Device Sequence Number: 8650979
• Product Code: MUJ
• UDI-Device Identifier: 07340201500064
• UDI-Public: (01)07340201500064(10)6.2.2.0
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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?: No
• Operator of Device: Health Professional
• Device Lot Number: 6.2.2.0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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