MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 0 - 1PK; TRUDI NAV SUCTION, 0

Catalog Number	TDNS000Z
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery (fess) procedure, the trudi navigation system was not accurate, using two trudi suction, 0 - 1pk (tdns000z, unknown lot) and trudi suction, 70 - 1pk (tdns070z, lot unknown).The caller noted that the trudi map was off anteriorly by approximately 5 mms.No troubleshooting was mentioned.The reporter noted that they continued the case with the inaccurate map.Several parts had previously been replaced and the issue still reoccurred.Registration probe & the suctions were not accurate according to the surgeon.Trudi system software version: 2.3.2.3.A shaver blade was used.There was no allegation that a death or serious injury occurred due to the use of the product.The patient did not require medical intervention as a result of the event.Additional event information received on 08-jul-2024 indicated that the customer confirmed accuracy using the registration probe after registration process was completed.The inaccuracy was determined by orbital rim bone.The inaccuracy was first noticed at registration.Registration probe and the suctions were not accurate according to the surgeon (all acclarent devices used).There were approximately 440 ct scan slices.The field of the view was axial.There were no noticeable defects to the ct scanned images.The registration was performed by the sales representative and then the physician who has performed approximately more than 100 registrations.Accuracy was confirmed in the orbital rim.There was no potential for metal interference.The information indicated that when the issue with the suction device occurred, the icon on the trudi system was green.There was no error message, just poor accuracy intraoperatively.The crosshairs turned yellow only after reaching the threshold of the trudi zone limit.The inaccuracy was not within 2 mm.The device has been re-processed approximately 10 times, each.The sterilization method used as per the instructions for use (ifu).
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.The device was discarded; therefore, no further investigation can be performed.The lot number is not known; therefore, a device history record review cannot be completed.With the information available and without the product available for analysis, the reported customer complaint could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by acclarent, or its employees that the report constitutes an admission that the product, acclarent, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.

• Brand Name: TRUDI SUCTION, 0 - 1PK
• Common Device Name: TRUDI NAV SUCTION, 0
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): VIANT MEDICAL; 45 lexington drive; laconia NH 03246
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19783109
• Report Number: 3005172759-2024-00076
• Device Sequence Number: 8181710
• Product Code: PGW
• UDI-Device Identifier: 10705031245877
• UDI-Public: 10705031245877
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/19/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown