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

Model Number	9735571
Medical Device Problem Codes	Mechanical Problem (1384); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used in a laser interstitial thermal therapy procedure.It was reported that there was an out of box issue with an instrument.During a case and removing instruments from the packaging, the instrument had a crack.The site opened up another instrument and proceeded with case.There was less than an hour delay to the case.No reported impact on the patient.Additional information was received that the crack in the bone anchor was notice during case setup and had no patient interaction.It was the white part of bone anchor, between the wings.
Additional Manufacturer Narrative
H3) the instrument was returned for analysis.As reported, the returned anchor had a crack in it.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; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22371073
• Report Number: 1723170-2025-02565
• Device Sequence Number: 7953375
• Product Code: GAH
• UDI-Device Identifier: 00763000416461
• UDI-Public: (01)00763000416461(17)270109(10)2025010024(20)01
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 9735571
• Device Catalogue Number: 9735571
• Device Lot Number: 2025010024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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 Age: 14 YR
• Patient Sex: Female
• Patient Weight: 102 KG