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)
Date of Event	04/15/2024
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 parts were not available for investigation.Based on previous investigations it is concluded that switching to a shorter screw, small locking margins and wear of parts, in combination has caused the problem.The ifu contains several warnings covering proper assembly and removing worn parts from clinical use.A check of lock of z-scales is added to the planned maintenance manual.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 the support arc shifted during operation.During an operation, the arc support shifted and after three times this problem persisted, which also resulted in an electrode being placed incorrectly.Worn parts were replaced and the lead was replaced without injury.

• 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: 22282536
• Report Number: 3015232217-2025-00042
• Device Sequence Number: 8467658
• Product Code: HAW
• UDI-Device Identifier: 07340048304849
• UDI-Public: 07340048304849
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: Non-Healthcare Professional
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• 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