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

Catalog Number	FG-2000-00
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trudi navigation system (fg-2000-00) "wouldn't navigate any suction or any navigation shaver blade.After opening many other products of different lot numbers, restarting the trudi navigation system twice, etc., they still would not navigate." the acclarent account manager plugged in a curette to test it and it was reportedly the only item that would navigate.The suction would show that it was plugged in, but when put in the ¿zone¿, it would not navigate.The shaver would also show that it was plugged in and was recognized in the field but showed a metal interference error.The account manager tested the devices on a model head after the case and had the exact same errors, not navigating the instruments.It was subsequently reported that there was a 45-minute delay in surgery.It is unknown whether the delay occurred prior to surgery or during surgery.
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, g6, h2, h3, h6, h11.A service order was opened for dispatch of a field service engineer (fse) to evaluate the reported trudi navigation system (fg-2000-00).The fse performed troubleshooting onsite and troubleshot the system with off-site engineers via phone and found that the console had an issue that required replacing the console and emitter pad (ep).The fse believed that the console may have overheated at some point.As a result, the ep & console were replaced along with nidaq cables.The system was tested and deemed ready for customer use.The complaint history of the system was reviewed, and no trends of this product issue were found.The cause of the issue was isolated to the navigation console.No further investigation is required based on the acceptability of risk.This will be monitored and trended going forward.At present, we consider this complaint to be closed.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, h2, h11.Corrected field: g4 (pma/510(k) #).

• 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: 23723691
• Report Number: 3003418325-2025-00066
• Device Sequence Number: 21493088
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2026

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 Catalogue Number: FG-2000-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 03/30/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/25/2026; 03/31/2026
• 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