MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. VISUALASE; POWERED LASER SURGICAL INSTRUMENT

Model Number	9735542
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: m 016445c001, serial/lot#: (b)(6), h3: a software analysis was initiated.No failure was found.It was determined to be a user error in failing to reboot mri computer on the scanner side as instructed caused the reported anomalous behavior of disconnections after any changes and/or refreshments meant to take effect for correct functionality did not complete as expected until the due reboot took place.Logs were analyzed.No anomalies were found from logs analysis.The reported issue was suspected to have originated outside the system, then suggestions for checking connections and router integrity, between others, were communicated to the field.H6: b01, c19 and d14 apply to the software analysis.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used during a soft tissue ablation (neuro) procedure.It was reported that the thermal ablation system disconnected from the mri during surgery on (b)(6) 2025.A manufacturer representative (rep) had done pre surgery checks and found that while testing thermal maps (tmaps) on a phantom kit, the scanner disconnected after running for a few minutes.The rep was able to replicate this but with various time before it disconnected.Rep checked tmap parameters, lowered scanner repetition time to decrease scan time, and checked connections with no success.Mri scanner application was rebooted, access-i router rebooted, ethernet cable swapped, pulled over another 2 plane tmap from a folder of protocols from install, checked parameters and used it.Rep was then able to run a 8-10+ minute tmap sessions with no abrupt disconnections.Rep was able to use thermal ablation system for two cases without issue.On the third case, they had completed multiple ablations with pullbacks before the system disconnected from the scanner on the last ablation before case completion.Rep ran a new session, but scanner disconnected again.Site cycled access-i router power, turned remote connection on scanner off/on, reselected sysconfig profile on the system, and rebooted it.Afterwards they were able to connect to the scanner long enough to complete the ablation.When having scanner disconnection, the system had error stating "mri scanner abruptly closed the access-i connection or reported an event, connection closed error ('code = 1006 (connection closed abnormally [internal]), no reason')" then got "cannot communicate with access- at the configured ip address, details: accessi command error" patient present.Additional information was received.It was reported that there was no impact to our final capability to effectively treat the patient.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: 9735718.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information was received.It was reported that there was a delay of 30 minutes.There was no impact on the patient's outcome.
Additional Manufacturer Narrative
H2: updates to b5.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H2, correction: previously concomitant product 9735718 not relevant to the complaint.H6: fdd a12 added to reflect the reported issue.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC.; 200 medtronic drive; lafayette CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23943669
• Report Number: 1723170-2026-00010
• Device Sequence Number: 7946504
• Product Code: GEX
• UDI-Device Identifier: 00643169655935
• UDI-Public: (01)00643169655935(11)160119
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/05/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9735542
• Device Catalogue Number: 9735542
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/05/2026; Not provided; 03/05/2026; 03/05/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/06/2026; 01/13/2026; 03/05/2026; 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2016
• 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 Age: 26 YR
• Patient Sex: Male
• Patient Weight: 95 KG