MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI PROBE, 0, 5IN; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number TDP0005

Device Problem Incorrect Interpretation of Signal (1543)

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery procedure, the trudi probe 0-degree, 5in (tdp0005 / 210310a-pc) was off in accuracy by about 4mm on the trudi navigation system.The registration probe was showing accurate; the registration probe was replaced without resolution.The trudi nav suction device was also replaced and the trudi navigation system showed ¿close to accurate.¿ the trudi probe was replaced and the issue resolved; the procedure continued.There was no report of any patient adverse event.On (b)(6) 2022, additional information was received.The information indicated that when the reported accuracy issue was observed, the icon on the trudi navigation system was green.There was no error message on the trudi nav monitor for the device.The information reported that the device was plugged in after registration.The patient tracker did not move; the patient tracer cable was not under tension in relation to the reported event.Axial computed tomography (ct) image was used as the primary image.Not more than one ct scan was attempted to be used with one device.The information stated that the inaccuracy issue was determined by verifying each instrument on the bridge of the patient¿s nose.There was no ferromagnetic material placed within the trudi zone.It was not known if the crosshairs turned yellow.The emitter pad did not move; the patient did not move.There was no other device¿s shaft in the proximity to an emitter pad¿s transmitter.Based on the additional information received on (b)(6) 2022, the accuracy issue was observed when the icon was green on the trudi system, the event has been deemed reportable as a ¿malfunction.¿.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).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 (210310a-pc) 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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery procedure, the trudi probe 0-degree, 5in (tdp0005 / 210310a-pc) was off in accuracy by about 4mm on the trudi navigation system.The registration probe was showing accurate; the registration probe was replaced without resolution.The trudi nav suction device was also replaced and the trudi navigation system showed ¿close to accurate.¿ the trudi probe was replaced and the issue resolved; the procedure continued.There was no report of any patient adverse event.On 01-dec-2022, additional information was received.The information indicated that when the reported accuracy issue was observed, the icon on the trudi navigation system was green.There was no error message on the trudi nav monitor for the device.The information reported that the device was plugged in after registration.The patient tracker did not move; the patient tracer cable was not under tension in relation to the reported event.Axial computed tomography (ct) image was used as the primary image.Not more than one ct scan was attempted to be used with one device.The information stated that the inaccuracy issue was determined by verifying each instrument on the bridge of the patient¿s nose.There was no ferromagnetic material placed within the trudi zone.It was not known if the crosshairs turned yellow.The emitter pad did not move; the patient did not move.There was no other device¿s shaft in the proximity to an emitter pad¿s transmitter.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile trudi probe was received contained in a decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The unit was sent to bwi-htc (haifa technology center) for robot location accuracy testing and magnetic calibration system (magcs) check.The unit failed the magcs calibration check for sensor sensitivity.However, when the unit was tested on the robcs (robotic calibration system) to determine the impact of sensor sensitivity failure on location accuracy; the unit passed for location accuracy, the unit meet the location accuracy specification of < 1 mm root mean square (rms) tool error.Based on the results provided by the bwi-htc team, the reported issue documented in the complaint was not confirmed.Although the unit was calibrated with a faulty dongle, causing failures in sensor sensitivity, the robcs test determined that the sensor accuracy was not affected.A review of manufacturing documentation associated with this lot (210310a-pc) 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 quality process all devices are manufactured, inspected, and released to approved specifications.Calibration with faulty dongles is being addressed through acclarent quality system.No corrective and preventive action (capa) activity is required at this time.Although no conclusion could be reached as to what may have caused or contributed to the event reported, the instructions for use (ifu) contains the following recommendations: before use, confirm the trudi¿ probe¿s location accuracy by checking the displayed position of the trudi¿ probe on several clearly identifiable anatomical structures.If the deviation is significant and is not resolved by repeating the registration of the ct or mri pre-operative scan on the system, do not use the trudi¿ probe.Ensure that device shaft and connectors do not come close to one of the transmitters on the trudi¿ emitter pad.If the shaft or connector is in proximity to a transmitter, location accuracy might be affected.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.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 that the product was received in the product analysis lab on 27-dec-2022.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.

• Brand Name: TRUDI PROBE, 0, 5IN
• Type of Device: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer (Section G): ACCLARENT, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 15982639
• MDR Text Key: 306976686
• Report Number: 3005172759-2022-00040
• Device Sequence Number: 1
• Product Code: PGW
• UDI-Device Identifier: 20705031464190
• UDI-Public: 10705031464193
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193453
• 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: 03/14/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2023
• Device Model Number: TDP0005
• Device Catalogue Number: TDP0005
• Device Lot Number: 210310A-PC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 12/27/2022; 03/14/2023
• Supplement Dates FDA Received: 01/09/2023; 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1