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

Model Number	MONACO
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect Measurement (1383)
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 a scan reference shift was incorrect.
Additional Manufacturer Narrative
H4 updated.H6 updated.H10 updated: the customer reported that a scan reference shift was incorrect.The shift was caught by the user prior to treatment with a 2.7 in/inf shift.This should have been a 2.7 out/sup shift.The user went back to the scan and reference setup page in monaco and it stated 2.7 n/inf shift and not 2.7 out/sup shift.The user tried to recreate the erroneous shift but was unable to recreate the issue each time it shows the correct shift 2.7 out/sup shift.During in-house testing, elekta performed the customer's workflow but could not reproduce the problem of the wrong scan reference shift.The behaviour of the product observed during testing was consistent and worked as designed and intended.Elekta have been unable to reproduce this issue.This appears to be a one-time occurrence and the cause could not be established.

• 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: 16742407
• Report Number: 3015232217-2023-00022
• Device Sequence Number: 5435474
• Product Code: MUJ
• UDI-Device Identifier: 00858164002275
• UDI-Public: (01)00858164002275(10)6.00.01
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 08/03/2023

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?: No
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• 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