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

Catalog Number	FG-2000-00
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trudi navigation system (fg-2000-00) displayed a red icon and error code 2100 when the emitter pad was connected.It was reported that there was a 30-minute surgical delay.No patient injury or death 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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g4 (pma/510(k) #), g6, h2, h3, h6, h11.To address the reported issue, the field service engineer (fse) instructed the integra/acclarent account manager to check the nidaq cable of the trudi navigation system (fg-2000-00) for any issues; however, the issue was still present.As a result, an fse was dispatched to evaluate the system.Upon arrival, the fse turned the system on and there were no error codes present.The log files of the system were reviewed and it was found that the system was turned off and on five times.The first four times the unit was turned on, the error was present.However, instead of an emitter pad coil issue or a nidaq issue, the issue was showing that the emitter pad was disconnected.On the 5th power cycle, there were no errors rendered and the system was also used for a case that same afternoon.All the following logs showed no errors.No other defects have been found with the system.There was no problem found with the system and it is ready for use.The complaint history of the system was reviewed, and no trends of the alleged product issue were found.

• 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: 22576002
• Report Number: 3003418325-2025-00048
• Device Sequence Number: 9646764
• 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): 09/03/2025

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 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: 06/26/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 09/03/2025
• 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