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

Catalog Number	FG-2000-00
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The surgeon reported that the trudi navigation system (fg-2000-00) was showing inaccurate readings.It was noted that inaccuracy was determined by placing the instruments/registration probe on the outside of the patient to confirm surgeon accuracy points.It was reported that there was a surgical delay of "60+ minutes".The procedure was concluded and no patient adverse event was reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h6, h11.The integra/acclarent representative discussed the inaccuracy issues that the doctor experienced with the trudi navigation system (fg-2000-00) and noted to have witnessed inaccuracy issues with clinical tools such as suctions, shaver and balloon.Clinical instruments seem to be off by a few millimeters according to the doctor.The field service engineer (fse) discussed different options such as bed type, environmental conditions, slower registration methods, and dongle compatibility of the system.The representative was unable to determine the root cause of inaccuracy.An integra/acclarent fse was dispatched for an on-site visit to troubleshoot the issue reported with the trudi navigation system.The fse visually inspected the trudi and found no damage to the cart or components.The system was found in good condition.The fse verified all cables were securely connected and organized.The fse double checked dongles for any mismatched revisions, but all dongles were the same revisions/compatible.The fse checked environmental conditions for any ferromagnetic interference.Metal levels were low.The fse performed basic functionality and acceptance testing procedures; in addition to performing multiple cube and noise tests, and the system passed all tests.During the first cube and noise tests, the registration probe had a difficult time confirming points for tracing.Registration had a delay when confirming points and the fse had a hard time pressing the proximal button.As a result, the fse replaced the registration probe with an extra probe from the account.The trudi passed cube and noise tests with the new registration probe and had a smoother time completing registration and tracing.The trudi navigation system was fully functional and available for use.No further investigation is required based on the acceptability of risk and no adverse trends identified.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) #).
Event or Problem Description
N/a.

• 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: 24068366
• Report Number: 3003418325-2026-00001
• Device Sequence Number: 9240960
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/06/2026; 03/30/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 02/24/2026; 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