MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 90 - 1PK; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number TDNS090Z

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Section d.4: 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.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Section h.3: 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 (2206109) 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 Description

The healthcare professional reported that during an in-office functional endoscopic sinus surgery (fess) procedure, the 90° trudi nav suction device (tdns090z / 2206109) was not navigating properly on the trudi navigation system.The 90° trudi nav suction device is under 30 uses.When the suction device was replaced, the issue was resolved.There was no report of any negative patient impact.On 09-apr-2024, additional information was received.Per the information, the sterilization method of the 90° trudi nav suction device cannot be confirmed.The reported issue that the device was not navigating properly occurred during use.When the issue was observed, the color of the icon of the device on the trudi system was green.There was no error message on the trudi nav monitor for the device.The 90° trudi nav suction device was plugged in after registration.Based on the additional information received on 09-apr-2024, the reported navigation issue has been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 24-apr-2024.A supplemental 3500a report will be submitted once the product investigation has been completed.Updated sections: b.4, d.9, 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The complaint product was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 90° trudi nav suction device was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The electrical functionality was tested, and the device was found to be out of the specifications for the sensor connectivity values, and shield connectivity to body values.A review of manufacturing documentation associated with this lot (2206109) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The reported issue documented in the complaint was confirmed due to the failure found on the electrical test.However, the root cause of such a finding remains unknown.It should be noted that product failure is multifactorial.However, instructions for use states that the user must confirm that trudi¿ suction is recognized and displayed by the trudi¿ system.The number of procedures that the trudi¿ suction was used with the trudi¿ system is presented in a circle.A green line at the bottom of the graphic reflects that the device is ready for the procedure.As part of acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.However, a capa was opened to address no recognition issues on suction devices.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.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, 90 - 1PK
• Type of Device: 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 ; 303552-689
• MDR Report Key: 19084202
• MDR Text Key: 340686437
• Report Number: 3005172759-2024-00024
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031245891
• UDI-Public: 10705031245891
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/08/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: TDNS090Z
• Device Lot Number: 2206109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/24/2024; 05/07/2024
• Supplement Dates FDA Received: 04/24/2024; 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1