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

Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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.During a dbs operation the z-scale shifted 2-3 mm.Screws had to be changed to another length to be able to fasten the z-scale and to continue the operation.This was noticed before leads were inserted.The slides were replaced and returned to elekta for investigation.Switching screw positions, small locking margins and wear of the parts in combination caused this problem.Investigation concludes the described scenario does not raise any new or unknown risks.Wear of the z-locking is a known problem.Spare parts are now available for replacement if they are found to be worn.The standard locking screw has large length tolerances and a rough end that wears the slide locking counterpart, this has been issued with a custom made screw which has a defined length and polished tip that does not cause wear.
Event or Problem Description
The customer reported that during a dbs operation the z-scale shifted 2-3 mm.Screws had to be changed to another length to be able to fasten the z-scale and to continue the operation.This was noticed before leads were inserted.

• Brand Name: LEKSELL VANTAGE ARC
• 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: 22282532
• Report Number: 3015232217-2025-00043
• Device Sequence Number: 8467656
• Product Code: HAW
• UDI-Device Identifier: 07340048304849
• UDI-Public: 07340048304849
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Physician
• 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: 10/10/2024
• 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