MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. VISUALASE; STYLET, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	9735571
Medical Device Problem Codes	Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used outside of a procedure.While walking through a demonstration, it was noticed that there was a saline leak/drip at the blue strain relief sheath while in the magnetic resonance imaging (mri) machine.Towels were used to contain the drippage and clean it up with no apparent damage caused.After the dry run, it was noticed that the local representative (rep) could just pull the outer canula of the inner canula/lumen as if the adhesion spot inside the blue strain relief was not holding.The rep had also noticed when they set up that the stiffening stylet was slightly difficult to insert, but it did pass with some friction.It was noted that the accessory kit was "way" past expiration date.It had expired on 2020-oct-25.There was no patient involvement.
Additional Manufacturer Narrative
A05: adhesion not holding, stylet difficult to insert a0504: saline leak d10: product id: unk_visualase_sys (serial: (b)(6); product id: 9735571 (2018101251); product type: 2543-mnav - system; h3, h6: no products were 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.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: STYLET, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: 22556422
• Report Number: 1723170-2025-02746
• Device Sequence Number: 15878188
• Product Code: GAH
• UDI-Device Identifier: 00643169933415
• UDI-Public: (01)00643169933415(17)201025(10)2018101251
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K081656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2025

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 Expiration Date: 10/25/2020
• Device Model Number: 9735571
• Device Catalogue Number: 9735571
• Device Lot Number: 2018101251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2018
• 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: Unknown