MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI NAVIGATION SYSTEM

Catalog Number	FG-2000-00
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power unit of the trudi navigation system (fg-2000-00) overheated during a demonstration case.The reporter stated that after two hours, they "touched the console and noticed it was extremely hot".Additionally, the reporter noticed an error message 2100 - overheating.There was no patient involvement and no injury was reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d9, g3, g4 (pma/510(k) #), g6, h2, h3, h6, h11.A field service engineer (fse) was dispatched to evaluate the trudi navigation system (fg-2000-00).The fse replicated the issue reported and observed the console red, and error 2100 on the trudi home screen.Fse accessed the location server and observed the last error.The fse inspected the nidaq cables and observed a stripped and broken pin on nidaq cable-1 stuck on the console.The fse then replaced the nidaq cables (1, 2 &3).Additionally, the fse replaced the console and emitter pad.The fse imported calibration files manually from the calibration files cd and verified other important calibration files.Finally, the fse performed cube and noise tests, which passed.

• Brand Name: TRUDI NAVIGATION SYSTEM
• Common Device Name: TRUDI NAVIGATION SYSTEM
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; 31 technology drive; CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine; CA 92618
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 22367376
• Report Number: 3003418325-2025-00029
• Device Sequence Number: 20813043
• Product Code: PGW
• UDI-Device Identifier: 10846835018639
• UDI-Public: 10846835018639
• Combination Product (Y/N): N
• PMA/510(K) Number: K231862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2025

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: Other
• Device Catalogue Number: FG-2000-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown