MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB MOSAIQ; ACCELERATOR, LINEAR, MEDICAL

Model Number	MOSAIQ
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the isocenter for cbct for imaging was different than the actual treatment.
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
H6 updated: h10 updated: the investigation found that a user/s had performed qa on a patient.The reference ct field was created so that they could obtain more anatomy on the image and the ct reference setup was 8cm inferior to the treatment isocenter.For the full course of treatment (28 fractions) the user/s imaged the daily cone beam ct but did not shift the patient 8cm superior when the actual treatment was delivered.The user/s did not realise this until the patient had completed treatment.For mosaiq for elekta linacs there is no requirement that the isocenter values match between ct and treatment fields or site setup definition/verification and treatment field definition/verification.For elekta machines, fields with different isocenters are allowed to be scheduled and treated in the same session.A warning is not expected if fields have different isocenters at the time of treatment whether this includes a ct field or not.The root cause is determined as use error as the user is expected to align the patient with the iso center to the machine that is delivering treatment through various clinical practises.Mosaiq did not have any malfunction and is working as intended.Due to a use error a geographic miss of 8 cm occurred.Based upon the information available the error affected all fractions and elekta physics have assessed this would be considered serious mistreatment.Considerations and information for users to prevent such use errors are already included within the instructions for use for mosaiq.

• Brand Name: MOSAIQ
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL
• 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 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 17370354
• Report Number: 3015232217-2023-00042
• Device Sequence Number: 14398901
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K183034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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
• Device Model Number: MOSAIQ
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2019
• 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