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

Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Event or Problem Description
The customer reported that the g-frame slipped during treatment.
Additional Manufacturer Narrative
The customer reported that the g-frame slipped during treatment.An investigation was attempted by conducting an evaluation of the product and the reported information.Elekta has not received the ct images from the customer, although they have been requested more than three times.The customer subsequently confirmed that they were unwilling to provide elekta with the ct images, therefore elekta were unable to perform a complete investigation.The frame and reusable fixation screws have been received and examined.The frame position, screw lengths used, screw penetration depth and screw angle versus the skull is therefore unknown and could not be analyzed.All parts, both fixation screws and frame, have passed their lifetime and this can be a contributing factor for the incident to occur.Based on the available information, the root cause is a combination of the following: the patient became agitated and twisted out of the frame.The body movement of the patient was observed, but not the resulting frame slippage.The patient did not notice that the frame slipped and therefore did not alert the operator.The operator did not pause the treatment to check the patient the second time.Factors like screw angle, patient anatomy at screw tips, torque used and frame placement are unknown factors that may have contributed to a less stable fixation.Worn and old equipment used past lifetime, especially the reusable fixation screws were used and could have been contributed to a less rigid fixation.The amount of radiation delivered to healthy tissue is unknown because it is not clear at what point the slippage occurred.Based on the available information, it was within a 15 minute time window.There is no feedback regarding patient injury or outcome.Elekta guarantee the leksell stereotactic system for 5 years from acceptance, and the reusable fixation screws for 1 year.This is documented in the instructions for use.The investigation found that all of the reusable fixation screws were manufactured more than eight years ago.The batch numbers indicate that no screws have been replaced during the year of usage of this kit.Although many of the screw tips show wear, there is no obvious damage that could explain the frame slippage.Therefore, it is unlikely that the tip sheared off and caused the frame slippage.The instructions for use contain several warnings about the importance of ensuring the frame does not move on the patient's skull.

• Brand Name: LEKSELL STEREOTACTIC 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 INSTRUMENT AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 21909181
• Report Number: 9612186-2025-00002
• Device Sequence Number: 18325003
• Product Code: HAW
• UDI-Device Identifier: 07340048305075
• UDI-Public: 07340048305075
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2025

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: 03/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2018
• 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