MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 70 - 1PK; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number	TDNS070Z
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.The trudi device does not have an expiration date; it is not a single use device.Trudi¿ suction instruments are supplied non-sterile and must be cleaned and sterilized prior to each usage.The device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot 2112087 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during a procedure on (b)(6) 2023, the trudi navigation system was showing inaccuracies during the procedure.The 70° trudi nav suction device (tdns070z / 2112087) was used and the inaccuracy was reported to be 3mm to 5mm off anteriorly.The icon on the trudi nav was green when the inaccuracy issue was noted.There was no error message.There was no report of any negative patient impact or patient injury.On (b)(6) 2023, additional information was received.The information indicated that the procedure was a primary hybrid functional endoscopic sinus surgery (fess); there were no non-acclarent devices used.The 70° trudi nav suction device had been reprocessed approximately 15 times via the automated method.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(4).The purpose of this mdr submission is to report that the product was received in the product analysis lab on 16-mar-2023.The returned product is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Additional Manufacturer Narrative
Manufacturer¿s ref.No.: (b)(6).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a procedure on (b)(6) 2023, the trudi navigation system was showing inaccuracies during the procedure.The 70° trudi nav suction device (tdns070z / 2112087) was used and the inaccuracy was reported to be 3mm to 5mm off anteriorly.The icon on the trudi nav was green when the inaccuracy issue was noted.There was no error message.There was no report of any negative patient impact or patient injury.On 24-feb-2023, additional information was received.The information indicated that the procedure was a primary hybrid functional endoscopic sinus surgery (fess); there were no non-acclarent devices used.The 70° trudi nav suction device had been reprocessed approximately 15 times via the automated method.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 70° trudi nav suction device was received contained in a decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The electrical functionality was tested, and the device was confirmed to be within specifications for all the connectivity and isolation values.The unit was then connected into the magnetic calibration system (magcs) for calibration check and it passed the test.Based on the results obtained, the reported issue in the complaint was not confirmed.The tool was found to be functional.A review of manufacturing documentation associated with this lot 2112087 presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of acclarent¿s quality process all devices are manufactured, inspected, and released to approved specifications.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: TRUDI SUCTION, 70 - 1PK
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• 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 ; 303552-6892
• MDR Report Key: 16449080
• Report Number: 3005172759-2023-00010
• Device Sequence Number: 5872732
• Product Code: PGW
• UDI-Device Identifier: 10705031245884
• UDI-Public: 10705031245884
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/06/2023

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 Model Number: TDNS070Z
• Device Catalogue Number: TDNS070Z
• Device Lot Number: 2112087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 03/16/2023; 04/06/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 03/16/2023; 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown