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

Model Number	1053958
Medical Device Problem Codes	Device-Device Incompatibility (2919); Compatibility Problem (2960); Unintended Compatibility (4047)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer has requested an accuracy check as they have experienced issues with accuracy.The customer has been using alpha omega's (third party], microdrive, which is non-compatible with leksell vantage.
Additional Manufacturer Narrative
Initial investigation is based on information from the user regarding the case and investigation of the arc system together with its frame holder.The system was investigated regarding accuracy.No mechanical faults that could explain a shift in the size reported could be found.The system is within speciation of mechanical accuracy.No injury of the patient has been reported.The root cause has not been confirmed yet.The customer has been using alpha omega's (third party], microdrive, which is non-compatible with leksell vantage.The manufacturer's investigation is on-going and further information will be provided once the investigation has completed.
Additional Manufacturer Narrative
D4 updated.H4 updated.H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the product and the reported information.The customer requested an accuracy check as they had seen a discrepancy when using the system for one dbs implantation.This site is using a microdrive supplied by a third party (alpha omega) in conjunction with the leksell vantage stereotactic system.The leksell vantage stereotactic system has been investigated regarding mechanical accuracy and it is well within specification.The leksell vantage stereotactic system has been investigated with an alpha omega microdrive but not the customer's own microdrive as this was not available for testing.The investigation concluded that microdrive (alpha omega) is incorrectly interfacing the leksell vantage stereotactic system in a way that it may cause a significant shift both anterior and lateral (accuracy error).This shift is seen for the system tested only and is judged to be highly dependent on the combination of microdrive (alpha omega) measurements and the stop holder measurements.Tests were also repeated with the leksell vantage stereotactic system using elekta microdrive which show much better accuracy (within specification) than using the alpha omega microdrive due to correct interfacing to the system.The root cause could therefore be concluded to be caused by incompatibility by a third party product.Alpha omega is claiming compatibility with all elekta instrument ab's stereotactic systems on the market.Elekta instrument ab has on several occasions informed alpha omega that interfacing towards only the stop holder is incorrect and will cause accuracy issues.Elekta instrument ab recommended alpha omega to review their interfacing design and stated that alpha omega cannot claim compatibility with elekta instrument ab's stereotactic systems.No injury of the patient have been reported and no replacement of leads were needed.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: pms ; cornerstone; london road; crawley, west sussex RH10 -9BL ; UK RH10 9BL
• MDR Report Key: 16137999
• Report Number: 9612186-2023-00001
• Device Sequence Number: 6651497
• Product Code: HAW
• UDI-Device Identifier: 07340048304399
• UDI-Public: 07340048304399
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 04/25/2023

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
• Device Model Number: 1053958
• 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: 11/22/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 01/11/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2022
• 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