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

Model Number	MONACO
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The issue was determined to be a defect in the product.The investigation found that the problem can happen with reshape contour and replace contour as well as any contouring tool that will activate a contour when the user clicks on the view.If a significant volume of a structure is missing, the dose distribution displayed will not represent the dose distribution delivered.Therefore the patient anatomy will not be accurately represented.The dvhs will not reflect the true volumes or the doses within those volumes.Concave structures which form a keyhole like structure in the sagittal or coronal views can show the largest volume change because when the recreated 3d volume is re-sliced, the inner volume will be deleted.Although other structures can have volume changes as well, these changes will be much smaller.No patients were mistreated.
Event or Problem Description
During an internal investigation, when editing a contour and clicking on a coronal or sagittal slice, the 3d volume is recreated unnecessarily which could result in a volume change.
Additional Manufacturer Narrative
H10.Additional information.The issue will be fixed in a future release of monaco® software.

• Brand Name: MONACO
• Common Device Name: SYSTEM, PLANNING, RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC; 1450 beale street; suite 205; st. charles, mo
• MDR Report Key: 9888950
• Report Number: 1937649-2020-00004
• Device Sequence Number: 10903010
• Product Code: MUJ
• UDI-Device Identifier: 00858164002268
• UDI-Public: 00858164002268
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2020

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 Model Number: MONACO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/28/2020
• Supplement Date Received by Manufacturer: 02/28/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 05/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1