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

Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the products and the reported information.The customer was delivering a step and shoot imrt.The linear accelerator started to radiate whilst the mlc (multi leaf collimator) was still moving to the next position and before the mlc had reached the expected position.Therefore it would be possible to deliver several mus (monitor units) with the mlc shape not in its final position, to body parts which were not expected to receive radiation dose.The integrity system has an interlock to interrupt or terminate the beam if any dose is detected by the monitoring system when no irradiation is expected (in this case, during a beam only segment).In this case the delivery was terminated by prf control error (item 7070).The machine behaved as intended and terminated the beam within a defined time when the machine parameters did not behave as expected.On (b)(6) 2025, 1 patient was affected by this issue and 7mu were delivered when the mlc was not in the correct position.The customer did 4 to 5 resets to complete the patient treatment, so a total of approximately 35mu were delivered.This has been assessed as an overdose of 0.35gy and resulted in more than 5% of the intended dose.This is considered a serious mistreatment.The investigation found that the root cause of this issue was due to a faulty serial link cable, which was causing the beam to start before the mlc had reached its final position.The connector was repaired and the machine tested, this resolved the issue.Elekta performed a risk assessment and assessed the severity of harm to be "serious" and probability to be "incredible".The risk assessment concluded that the risk is considered low.
Event or Problem Description
The customer reported that when delivering step and shoot imrt beams on this machine, the beam started prior to the mlc leaves being in their final position.

• Brand Name: VERSA HD
• Common Device Name: ACCELERATOR, LINEAR, MEDICAL,
• 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: 21632534
• Report Number: 3015232217-2025-00003
• Device Sequence Number: 21141010
• Product Code: IYE
• UDI-Device Identifier: 05060191071574
• UDI-Public: 05060191071574
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K210500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown