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

Lot Number	11.4.2
Medical Device Problem Codes	No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
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 an issue with the cbct system during co-registration where sometimes the images do not appear after acquisition, or are getting assigned to the wrong patient.
Additional Manufacturer Narrative
H11 updated: the customer reported an issue with the cbct system during co-registration where sometimes the images do not appear after acquisition, or are getting assigned to the wrong patient.An investigation was attempted by conducting an evaluation of the product and the reported information.The issue could not be reproduced and it has not recurred at the customer site.Attempts to obtain additional information from the customer were unsuccessful.The gamma knife log file analysis does not show any irregularities concerning the cbct image creation.The logfile clearly indicates that the cbct images have been reconstructed and shown.However, other hardware related problems may play a role here which would not be detected by log file analysis.Hardware related problems would be expected to have more significant impact than indicated by the customer.Regarding the issue with the cbct images being connected to the incorrect patient, this has not been possible to confirm in the logfiles.No indications of anything irregular have been found.The log file analysis indicate that the system is working as intended.It has not been possible to establish the root cause.The risk of cbct images being connected to the wrong patient is a well-known risk with multiple mitigations in place.There are no indications from the log files that the mitigations have failed or even been activated.The existing risks are deemed adequately mitigated.Since the cbct functionality was released to customers in 2015 no cases of cbct images being connected to the wrong patient examination in lgp have been reported.Based on available information, there was no mistreatment.

• 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, 11368 ; SW 11368
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 23664380
• Report Number: 3015232217-2025-00073
• Device Sequence Number: 10282957
• Product Code: IWB
• UDI-Device Identifier: 07340201502136
• UDI-Public: 07340201502136
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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 Lot Number: 11.4.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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