MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 0 DEG

Catalog Number	TDNS000Z
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2025
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
It was reported that during functional endoscopic sinus surgery, the trudi suction, 0-degree (b)(6) displayed a red error signal once plugged in, after registration.The trudi navigation system indicated a navigated instrument error and to replace device after 10 uses.The device had only been plugged in for 30 seconds.It was subsequently reported that there was a 30-minute delay in the case because the backup 0-degree suction also gave a red error code and couldn¿t be used.Staff had to wait for the third set of suctions to be done sterilizing.It was reported that the patient outcome was unaffected.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The suspected trudi suction, 0-degree (tdns000z) was not returned for evaluation.The customer-provided image was used to confirm product identification.The image was inconclusive of the reported issue since it does not show the trudi navigation system monitor in which would display any error codes/messages received.It was noted that part testing is not required as part of this complaint because there is a corrective and preventative action investigating the root cause of suction devices with failures related to sensor navigation.This will be monitored and trended going forward.At present, we consider this complaint to be closed.

• Brand Name: TRUDI SUCTION, 0 DEG
• Common Device Name: TRUDI SUCTION
• 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: 23767586
• Report Number: 3003418325-2025-00067
• Device Sequence Number: 10562235
• Product Code: PGW
• UDI-Device Identifier: 10705031245877
• UDI-Public: 10705031245877
• Combination Product (Y/N): N
• PMA/510(K) Number: K180948
• 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): 01/28/2026

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: TDNS000Z
• Device Lot Number: 2410300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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