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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2022
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 plan exported from monaco differs to what is being displayed by isodoses and dvh.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported that the plan exported from monaco differs to what is being displayed by isodoses and dvh.The investigation found that a sequence of steps performed by the user, consisting of an initial optimization, expansion of a structure or the creation of a new margin structure outside of the external contour and without forced density, change of the optimization criteria, and continuation of the optimization, may result in apertures that deliver doses on an incorrectly shifted position of the target - a geometrical miss.Moreover, after the final optimization, it is possible that the dose distribution in monaco® looks like it is conforming to the target at the original location, as desired.However, if the plan is delivered to the patient, the delivered dose may be shifted and will not match the dose distribution calculated in monaco®.The problem will not occur if the added contour outside the external contour has an assigned density.The clinical impact of such an error is directly affected by the size of the geometrical miss (shift), which can range from zero or negligible to a few centimeters, depending on how much the dose calculation extent is expanded after adding the contour outside the patient.Plans created with monaco, 5.11.00, 5.11.01, 5.11.02 and 5.11.03 using a specific workflow could be affected.Elekta performed a risk assessment and assessed the severity of harm to be serious with a probability of uncommon.There was no patient mistreatment.An important field safety notice (382-01-mon-023) was released on 28-feb-2023 to affected customers to inform them of the product issue (elekta fca reference no: (b)(4)).Monaco® customers who have created plans with monaco, 5.11.00, 5.11.01, 5.11.02 and 5.11.03 using a specific workflow could be affected.Customers have been advised on the field safety notice that if they are running monaco version 5.11.Xx to contact elekta to upgrade to a newer software version and if they need assistance to identify any affected patient plans.

• Brand Name: MONACO
• Common Device Name: SYSTEM,PLANNING,RADIATION THERAPY TREATMENT
• Manufacturer (Section D): ELEKTA INC.; 1450 beale street; suite 205; st. charles MO 63303
• Manufacturer (Section G): ELEKTA INC.; 400 perimeter center terrace; suite 50; atlanta GA 30346
• Manufacturer Contact: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 16246476
• Report Number: 1937649-2023-00001
• Device Sequence Number: 12363868
• Product Code: MUJ
• UDI-Device Identifier: 00858164002169
• UDI-Public: (01)00858164002169(10)5.11.02
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2023

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
• Device Model Number: MONACO
• 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: 12/28/2022
• Supplement Date Received by Manufacturer: 12/28/2022
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2017
• 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