MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB LEKSELL GAMMAPLAN; RADIONUCLIDE RT TREATMENT PLANNING SYSTEM

Lot Number	11.4.1
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	02/25/2025
Type of Reportable Event	Serious Injury
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 a mismatch of mr vs cbct #2.
Additional Manufacturer Narrative
H11 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer reported a mismatch of mr vs cbct #2.An avm treatment was planned on (b)(6) 2025 using frame-based mri and angio images from (b)(6) plus current cbct images.The created plan was incorrectly based on the non-current frame-fixation from (b)(6) and was not correctly updated for the current mask fixation represented by the current cbct images.The misalignment was not detected by the user and the plan was approved and delivered.The root cause is that the plan was not properly updated after changing fixation.The clear discrepancies that this caused were not properly reviewed or acted upon before the approval of the plan.The system worked as designed and intended.Elekta have not been provided with information regarding the patient's condition.An important field safety notice (100-01-102-019) has been sent to all affected customers from 17 december 2025 (elekta reference #: fca-esab-0010).To reduce the likelihood for erroneous use of obsolete stereotactic reference for treatments with a frame, leksell gammaplan® 11.5 will no longer permit the use of stereotactic cbct reference in combination with other stereotactic references.

• Brand Name: LEKSELL GAMMAPLAN
• Common Device Name: RADIONUCLIDE RT TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 23423452
• Report Number: 3015232217-2025-00069
• Device Sequence Number: 21298035
• Product Code: MUJ
• UDI-Device Identifier: 07340201502136
• UDI-Public: 07340201502136
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232854
• 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
• Remedial Action: Modification/Adjustment,Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

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?: No
• Operator of Device: Health Professional
• Device Lot Number: 11.4.1
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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