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

Medical Device Problem Codes	Computer Software Problem (1112); Loss of Data (2903)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that brain -ptv (planned target volume/planning tumour volume) is read by monaco as brain +ptv and there is no alert from monaco.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
B1 updated.H2 updated.H6 updated.H10 updated.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported concerns about contours coming from a third party contouring tool when holes were created.In customer informed that with this case "brain - ptv" was read by monaco as "brain + pvt" and no alert was received from monaco.The investigation found that this issue is a limitation of the dicom standard which does not give clear guidance on the handling of donut contours.The result is that different manufacturers will handle the import of donut contours in different ways.The handling of donut contours for monaco is explained in both the online help as well as in the instructions for use.Monaco also displays its interpretation of contours it has imported and provides tools for the user to review contours/densities/occupancy, etc.Monaco did not have a malfunction and worked as designed and intended.Based upon the available information there has been no mistreatment.

• Brand Name: MONACO
• Common Device Name: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; kungstensgatan 18; box 7593; stockholm, SE-10 3 93; SW SE-103 93
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta GA 30345
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 17697809
• Report Number: 3015232217-2023-00053
• Device Sequence Number: 7510746
• Product Code: MUJ
• UDI-Device Identifier: 07340201500033
• UDI-Public: (01)07340201500033
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K213787
• 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): 11/30/2023

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: Health Professional
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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