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

Model Number	1053958
Medical Device Problem Codes	Failure to Align (2522); Compatibility Problem (2960); Unintended Compatibility (4047)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Insufficient Information (4580)
Date of Event	04/11/2023
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 has reported a position discrepancy when positioning dbs electrode.The customer has been using fhc's microdrive (third party).Elekta is not claiming compatibility with fhc's microdrive.
Additional Manufacturer Narrative
Updated.Expiration date: the expiration field completion on the initial report was erroneously completed.There is no expiration date updated.Device manufacture date has been corrected from (b)(6) 2018.The investigation was completed by conducting a thorough evaluation of the product and the reported information.It was reported by the user that they have seen a discrepancy when using the system for dbs implantations.This site is using a microdrive supplied by a third party (fhc) in conjunction with the leksell vantage stereotactic system.The leksell vantage stereotactic system has been investigated regarding mechanical accuracy and it is within specification.The leksell vantage stereotactic system has also been tested with the customer's fhc microdrive.It was found that the fhc microdrive itself introduces a consistent shift of approximately 1.2 mm in the same direction that the user has experienced.The fhc microdrive is assembled only to the stop holder without attachment to the guide holder, which is not the intension of the elekta systems.Interfacing towards only the stop holder is incorrect and will cause accuracy issues.The fhc microdrive is not verified by elekta to be compatible.In this case the root cause of the large shift (apart from the consistent shift of using the fhc microdrive) is probably caused by human error during setting of scales or assembling the vantage arc system or the fhc microdrive.This cannot be verified afterwards.A patient sustained a small haemorrhage, which did not require any intervention and revision of one electrode was necessary.No product related issues could be found with leksell vantage stereotactic system.

• Brand Name: LEKSELL VANTAGE ARC
• 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: 16910418
• Report Number: 9612186-2023-00005
• Device Sequence Number: 6170399
• Product Code: HAW
• UDI-Device Identifier: 07340048304399
• UDI-Public: 07340048304399
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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
• Device Expiration Date: 08/23/2018
• Device Model Number: 1053958
• Device Lot Number: SH00134
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 08/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2018
• 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