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

Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
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 patients head was out of position during lgk treatment.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the reported information.The customer informed that the patient became dislodged from the head frame.The hospital staff had not noticed any movement of the patient during the treatment, however all four pins from the frame were at a different location.No injury of the patient has been reported by the customer but the treatment had to be re-started with a new fixation.Movement of the patient in the gamma knife resulted in the patient's skull being outside the radiation focus.It is uncertain how much radiation the patient missed in the target since it is unknown when the patient moved.No ct or cbct images have been received from the customer to verify the frame position as well as the radiation target.There is no reason to suspect that there is something wrong with the vantage equipment and no damages could be seen on the firmfix used.The root cause is identified to be use error where the firmfix was fixated with too low torque and probably high position of the frame on the head as the patient did not have any lacerations of the skin but this has not been fully verified.The customer has been informed regarding the difference in torque between the g-frame (used by customer since 2005) and the vantage frame and has received the white paper regarding this (leksell vantage stereotactic system head frame fixation - (b)(6)).

• Brand Name: LEKSELL VANTAGE STEREOTACTIC SYSTEM
• Common Device Name: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; kungstensgatan 18; po box 7593; stockholm, SE103 93; SW SE103 93
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 16654840
• Report Number: 9612186-2023-00004
• Device Sequence Number: 6071936
• Product Code: HAW
• UDI-Device Identifier: 07340048305167
• UDI-Public: 7340048305167
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 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): 08/30/2023

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?: 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: 03/03/2023
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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