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

Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that chipped and fading paint in the arc engravings.
Additional Manufacturer Narrative
A retrospective review of this case has been conducted with the conclusion to file an mdr report for this event.Some of the millimeter markings on the x-axis had been washed off during cleaning process and identified upon opening the procedure tray.No incident occurred.The systems had been processed a total of 3 times each using recommended detergent from the ifu as well as manufacturer recommended steam sterilization protocol.Investigation could not identify a clear root cause but likely a contamination in production of the unit either via improper cleaning or contamination in handling the product.There is a very low probability of the paint itself causing harm if entering the brain.The worst case is assessed as critical hazard which may cause severe injury, severe occupational illness or major system damage.No patient injuries or cases where paint has entered the wound have been reported.A capa has already been implemented revising the manufacturing process, and no further events have been reported.

• Brand Name: LEKSELL VANTAGE ARC SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT 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: 22183360
• Report Number: 9612186-2025-00004
• Device Sequence Number: 8617442
• Product Code: HAW
• UDI-Device Identifier: 07340048304849
• UDI-Public: 07340048304849
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: 10/18/2019
• Initial Report FDA Received Date: 06/11/2025
• Date Device Manufactured: 11/20/2018
• 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