MAUDE Adverse Event Report: ELEKTA SOLUTIONS AB LEKSELL VANTAGE STEREOTACTIC SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A retrospective review of this case based on fda inspection may 22, 2025 has been conducted with the conclusion to file an mdr report for this event.The customer reported that a nurse managed to attached the frame holder incorrectly resulting in dbs electrode being misplaced by ~1cm.The position was corrected using a different frame holder.The hospital confirmed that the patient was alright.The user is experienced but may have been distracted because of a student in attendance.A non-transparent drape was used, the mis-docking could have been detected at this stage, it was detected when the drape was removed.No additional images were taken and the electrode ended up in the correct position.The hospital switched to a different frame from another department.There were no problems attaching the support arc.The frame holder was not returned for investigation, but photographic evidence was provided.The dbs misplacement was caused by a use error when docking the frame holder to the frame.This specific use error has never occurred in the past.The dbs probe was re-implanted without causing any bleeding or other injury to the patient.No corrective or preventative determined necessary.
Event or Problem Description
The customer reported that a nurse managed to attached the frame holder incorrectly resulting in dbs electrode being misplaced by ~1cm.The position was corrected using a different frame holder.

• Brand Name: LEKSELL VANTAGE STEREOTACTIC SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA SOLUTIONS AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA SOLUTIONS AB; 400 perimeter center terrace; suite 50; atlanta, ga 30346 ; SW 30346
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 22282531
• Report Number: 3015232217-2025-00040
• Device Sequence Number: 15570219
• Product Code: HAW
• UDI-Device Identifier: 07340048311410
• UDI-Public: 07340048311410
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K190887
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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?: Yes
• Operator of Device: Health Professional
• 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: 02/18/2025
• Initial Report FDA Received Date: 06/18/2025
• 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