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

Model Number TDNS000Z

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a primary functional endoscopic sinus surgery (fess) procedure, the 0° trudi nav suction device (tdns000z / lot# 1905030 / serial# 1905030038) was reported as not operating correctly and was showing up inaccurately.There was no report of any patient adverse event or patient complication.Additional information was received on 01-feb-2022.The information indicated that the device was sterilized in accordance with the instructions for use (ifu).When the reported accuracy issue was observed, the icon on the trudi system was red.The device was plugged in after registration.Computed tomography (ct) image was used as the primary image.The quantity of slice the ct scan contained is not known.The inaccuracy issue was visually determined; the inaccuracy was not within 2mm.There was no ferromagnetic material placed within the trudi zone.It is not known if the crosshairs turned yellow.The emitter pad and the patient did not move.It was not known if other device¿s shaft was in the proximity to an emitter pad¿s transmitter.The complaint device was returned for evaluation and analysis.Based on the result of the product analysis completed on 26-apr-2022, the reported issue has been deemed us fda mdr reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(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.[conclusion]: the healthcare professional reported that during a primary functional endoscopic sinus surgery (fess) procedure, the 0° trudi nav suction device (tdns000z / lot# 1905030 / serial# (b)(4) was reported as not operating correctly and was showing up inaccurately.There was no report of any patient adverse event or patient complication.Additional information was received on 01-feb-2022.The information indicated that the device was sterilized in accordance with the instructions for use (ifu).When the reported accuracy issue was observed, the icon on the trudi system was red.The device was plugged in after registration.Computed tomography (ct) image was used as the primary image.The quantity of slice the ct scan contained is not known.The inaccuracy issue was visually determined; the inaccuracy was not within 2mm.There was no ferromagnetic material placed within the trudi zone.It is not known if the crosshairs turned yellow.The emitter pad and the patient did not move.It was not known if other device¿s shaft was in the proximity to an emitter pad¿s transmitter.The 0° trudi nav suction device was returned for evaluation.The investigational finding is documented below.Investigation summary: the 0° trudi nav suction device was received; visual inspection and functional testing were performed.There was no apparent damage observed on the returned 0° trudi nav suction device.The device was tested for electrical functionality.All values were observed within specification.The device was connected to the trudi system; it was recognized with no errors and it was indicated that the trudi nav suction device was on its 14th use.A cube was registered on the trudi system.The suction complaint device was held in various positions around the cube.The caliper tool in the trudi planning tab was used.The device was fully inserted into a hole on the front face of the cube.The distance between the crosshair representing the device tip location and the back wall of the hole was measured to be about 1.6mm (z-axis), and the distance between the crosshair representing the tip location and the hole center was measured to be about 1.4 mm (xy plane).The total position of the tip was calculated to be about 2.1 mm from where the device was physically.The complaint of inaccuracy of 2 mm was confirmed during analysis, which included cube registration and placement of the complaint device.A review of manufacturing documentation associated with this lot (1905030) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of acclarent quality process, all devices are manufactured, inspected, and released to approved specifications.However, inaccuracy issues on trudi suction devices is being addressed through acclarent quality system.It should be noted that product failure is multifactorial.However, the ifu states that before use, confirm the trudi¿ nav suction¿s location accuracy by checking the displayed position of the trudi¿ nav suction on several clearly identifiable anatomical structures.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, 0 - 1PK
• Type of Device: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14215337
• MDR Text Key: 295794352
• Report Number: 3005172759-2022-00007
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 10705031245877
• UDI-Public: 10705031245877
• 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
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TDNS000Z
• Device Catalogue Number: TDNS000Z
• Device Lot Number: 1905030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1