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

Model Number MOSAIQ

Device Problem Computer Software Problem (1112)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer reported that the isocenter for cbct for imaging was different than the actual treatment.

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.

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
• Type of Device: 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
• MDR Text Key: 319484486
• Report Number: 3015232217-2023-00042
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00858164002282
• UDI-Public: (01)00858164002282(10)2.81.070
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: MOSAIQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2023
• Initial Date FDA Received: 07/21/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1