MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB LEKSELL VANTAGE HEAD FRAME; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number	1051800
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 a patient became disengaged from the head frame.
Additional Manufacturer Narrative
D1 updated.Product changed from leksell vantage arc system to leksell vantage head frame.The investigation was completed by conducting a thorough evaluation of the reported information.The customer informed that with five minutes remaining in a one-hour treatment the patient became disengaged from the vantage head frame.This was noticed audibly and visually and was attributed to excessive movement by the patient.The remaining treatment was completed with mask immobilization.No injuries or mistreatment to the patient were reported.There is no reason to suspect that there is something wrong with the vantage equipment.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 (which was reported to be conical) in combination with movement of the patient.The user has been informed regarding the difference in torque between the g-frame (previously used by the customer) and the vantage frame and has received the white paper regarding this (leksell vantage stereotactic system head frame fixation - llfvan190624).

• Brand Name: LEKSELL VANTAGE HEAD FRAME
• 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: 17143049
• Report Number: 9612186-2023-00006
• Device Sequence Number: 7663276
• Product Code: HAW
• UDI-Device Identifier: 07340048305167
• UDI-Public: 07340048305167
• Combination Product (Y/N): N
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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
• Device Model Number: 1051800
• Device Catalogue Number: 1051800
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2021
• 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