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

Model Number	9735560
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
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 there was a tumor in the amygdala with a large calcium deposit in the middle which obscured the imaging, heat spread, and temperature map (tmap).After two initial heat attempts and uneven, inaccurate heat readings corresponding to the amount of power, a pullback was made to determine if it was the calcium deposit that was the issue, or if it was the fiber.They reheated in a new spot and had the same low heat profile.The laser fiber was broken clean at the tip with slight charring discoloration, but it was not melting the fiber nor the catheter.Also, the catheter had been tightened too tightly at the bone anchor and was broken at the anchor site.It held together and was not detectable until they had to remove the broken laser fiber, which was not easily removed due to the tightening at the bone anchor.The bone anchor blue cap was loosened, the fibers were exchanged and that was when the surgeon saw bending on the catheter.Water was ran to determine the damage and water return.It was noted that saline was returning to the drainage bag but very slowly, leaking enough that there was not detectable slowing in the drip chambers.There were three ablations performed in the end with a new fiber.There were three performed with the first broken fiber.Two were in the same spot, and then one pullback to a different spot.The case was finished successfully.There was a reported delay to the procedure of more than 1 hour due to this issue.Post-operative magnetic resonance imaging (mri) scans revealed no unwanted damage.The patient woke up fine.The products were broken, but i tact with nothing left in the patient.There was no reported impact on patient outcome.
Additional Manufacturer Narrative
H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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.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 XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 21731698
• Report Number: 1045254-2025-01008
• Device Sequence Number: 12945344
• Product Code: GEX
• UDI-Device Identifier: 00763000416430
• UDI-Public: 00763000416430
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2025

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: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0229951066
• 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: 03/26/2025
• Initial Report FDA Received Date: 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Male