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

Medical Device Problem Codes	Computer Software Problem (1112); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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
The customer reported that the ctv (clinical target volume) volume changes during ats (adapt to shape).
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that the ctv (clinical target volume) volume changes during ats (adapt to shape).It was ascertained from the investigation that when calculating the area of a contour, a number of contour points are used to form a polygon.The more points used, the more accurate the area calculation.When adapting the anatomy, new contour points are generated which can differ from the original and will result in a different area computation.Since the volume of a structure is then calculated from the contour area, small differences in structure volume would be expected.These slight volume changes have been assessed as clinically insignificant.Monaco did not have any malfunction and was working as designed and intended and based on the available information there has been no patient mistreatment.

• 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; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 18985284
• Report Number: 3015232217-2024-00000
• Device Sequence Number: 8530493
• Product Code: MUJ
• UDI-Device Identifier: 07340201500064
• UDI-Public: (01)07340201500064(10)6.2.1.0
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K202789
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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