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	08/14/2026
Type of Reportable Event	Malfunction

• 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 ; +1(609)936-2319
• MDR Report Key: 50763388
• Report Number: 3003418325-2026-00038
• Device Sequence Number: 9395633
• Product Code: PGW
• UDI-Device Identifier: 10846835018639
• UDI-Public: 10846835018639
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K231862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/14/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown