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

Catalog Number	FG-2000-00
Medical Device Problem Code	Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "since the emitter pad replacement, the trudi navigation system (fg-2000-00) has consistently malfunctioned.Upon startup, the console displays red, requiring you to reload application.In every case, placing the patient tracker results in an orange indicator and error 3301: ¿navigated device is close to the trudi zone limit.¿ today, after registering successfully, the trudi tracker turned red when attempting to use the bien air debrider, the system lost navigation, and the surgeon was unable to navigate any instruments.Multiple tracker replacements and three system reboots failed to resolve the issue.The fourth tracker turned orange and after significant troubleshooting, we were finally able to register, but this process delayed the case by over an hour while the patient was under anesthesia.Throughout the procedure, the system intermittently lost navigation." it was reported that no patient injury or death occurred.
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 field service engineer (fse) was dispatched to evaluate the trudi navigation system (fg-2000-00).The fse confirmed the issues with the trudi system.Multiple errors were found in the location server.After many troubleshooting attempts, the fse swapped the instrument hub from the loaner system with the instrument hub from the customer trudi to resolve the error 1134.The fse resolved the error 1135 by switching off the console and back on after a few seconds from the gui.The fse completed cube and noise tests which passed.The system was ready for use.A complaint history of the system was reviewed, and no trends of this product issue were found.The root cause remains unknown.It should be noted that the product failure was multifactorial.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d9, g3, g4 (pma/510(k) #), g6, h2, h3, h11.
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: 22107660
• Report Number: 3003418325-2025-00021
• Device Sequence Number: 8149856
• 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,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: 05/06/2025
• Supplement Date Received by Manufacturer: 07/02/2025; 07/24/2025; 03/30/2026
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/24/2025; 07/28/2025; 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