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

Catalog Number	FG-2000-00
Medical Device Problem Code	Electromagnetic Interference (1194)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A service/repair request was opened for the trudi navigation system (fg-2000-00).A field service engineer (fse) was assigned and provided remote support to the sales representative regarding the reported ferromagnetic interference error.The fse advised the sales rep that a software upgrade can potentially resolve the error and was awaiting confirmation from the sales rep on the version of the workstation (ws).During a follow-up call by the fse, the sales rep provided the version of the ws; however, it was determined that a software upgrade was not needed anymore since the system was now functioning properly.As a result the service/repair request was closed and onsite visit was no longer required.The complaint history of the system was reviewed, and no trends of the alleged reported issue were found.
Event or Problem Description
It was reported that the "trudi navigation system (fg-2000-00) was showing error code 3126, ferromagnetic interference on two of the three dongles.Staff was not able to clear the error during the case and the trudi navigation system was not able to work at all.Staff tried unplugging dongles, unplugging instruments, turning off the trudi and reregistering.None of these troubleshooting measures corrected the problem." it was reported that the acclarent representative went on site "after the cases and was able to recreate the problem" but was not able to correct it.It was noted that the trudi navigation system needed to be serviced and equipment potentially replaced and software updated.It was subsequently reported by the acclarent regional business manager that the issue occurred multiple times during this procedure and the system was shut down completely and restarted and had to reregister.This reportedly caused an increase in surgery time, totaling about 30 minutes, no adverse effect to the patient.The doctor was able to complete the procedure using his other tools, without using the trudi navigation system.It was noted that no medical intervention was required.
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: 24033379
• Report Number: 3003418325-2025-00068
• Device Sequence Number: 9140283
• 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
• 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: 12/18/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 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