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

Model Number	9735559
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: no parts have been received by the manufacturer for evaluation.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 after a procedure in which three laser catheters were sequentially connected, a manufacturer representative (rep) noticed the third catheter's tip was charred.There were no issues with the procedure outcome.The first two laser ablations had no issues, but on the third the rep noticed some abnormal heating at the tip.Several minutes in, there may have been a "bubble event" or "steam event".The system shut off, but after it rebooted the procedure proceeded normally.There was no delay and no impact on patient outcome.
Additional Manufacturer Narrative
Additional information in d4.H3, h6: the catheter, lot number: 0231008401, was returned to the manufacturer for analysis.The returned catheter was burnt at the tip.Codes b01, c07 and d02 are applicable to this 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.

• 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: 22437672
• Report Number: 1723170-2025-02627
• Device Sequence Number: 4708337
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: (01)00763000416430(17)270327(10)0231008401(20)01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K053087
• 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
• Report Date (Section B): 07/30/2025

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: 9735559
• Device Catalogue Number: 9735559
• Device Lot Number: 0231008401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 34 KG