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

Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer contacted elekta to ask whether the "shot coordinates" in the gk treatment plan report represent absolute couch coordinates (in the machine's frame of reference) or if they vary depending on which scan is used as the stereotactic reference.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the products and the reported information.The investigation found that the user mistakenly used a 2 month old cbct image representing an obsolete fixation of the g-frame as a stereotactic reference.The system would have displayed a warning to the user, before the plan could be approved.The plan was approved and the treatment was delivered using the old cbct image, resulting in a mistreatment approximately 10 mm from the intended position.The state of the patient is not known.The device did not have any malfunction and worked as designed and intended, the root cause was use error.

• Brand Name: LEKSELL GAMMAPLAN
• Common Device Name: RADIONUCLIDE RT TREATMENT PLANNING SYSTEM
• Manufacturer (Section D): ELEKTA INSTRUMENTS AB; hagaplan 4; stockholm, sweden 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: 21311042
• Report Number: 9612186-2025-00001
• Device Sequence Number: 12987639
• Product Code: MUJ
• UDI-Device Identifier: 07340048311878
• UDI-Public: 07340048311878
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2025

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
• 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: 01/08/2025
• Initial Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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