MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI PROBE, 70, 5IN; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Model Number	TDP0705
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Conclusion: the healthcare professional reported that during a primary functional endoscopic sinus surgery (fess) and septoplasty procedure, the location accuracy of the trudi probe 70, 5in (tdp0705 / 210226b-pc) was off.The location of the probe that was displayed on the trudi system appeared to be 4 or more mm off.The further posterior and superior that they moved the probe, the less accurate the location of the probe seemed to be.The probe was registered two times without resolution.The procedure was continued without the use of the probe.On 01-jun-2022, additional information was received.The information indicated that when the accuracy issue was noted, the trudi probe was being held in the trudi zone.The icon on the trudi system was green.There was no error message on the trudi nav monitor for the device.The device was plugged in after registration (i.E., using the registration probe).The patient tracker was not moved and the patient tracker cable was not under tension in relation to the event.Troubleshooting was performed in that the device was plugged into a different port as well and it was registered twice.The inaccuracy was determined ¿first by the suctions which were probably over 4mm off.Then we proceeded with the probe that was also off by over roughly 2mm.We checked by using anatomical structures including skull base.It showed that it was inferior to skull base even when we could see it was hovering right on it in the scope view.¿ there was no ferromagnetic material placed within the trudi zone.The crosshair did not turn yellow.The emitter pad and the patient did not move.There was no other device¿s shaft in the proximity to the emitter pad¿s transmitter.Based on complaint information, the device is not available to be returned for analysis.A review of manufacturing documentation associated with this lot (210226b-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.All product rejected during manufacturing was identified as scrap and properly accounted for.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.No determination of causes and possible contributing factors could be made.As a result, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint cannot be confirmed.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint sample; however, it is possible that clinical and procedural factors, including device manipulation may have contributed to the reported failure.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.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 primary functional endoscopic sinus surgery (fess) and septoplasty procedure, the location accuracy of the trudi probe 70, 5in (tdp0705 / 210226b-pc) was off.The location of the probe that was displayed on the trudi system appeared to be 4 or more mm off.The further posterior and superior that they moved the probe, the less accurate the location of the probe seemed to be.The probe was registered two times without resolution.The procedure was continued without the use of the probe.On 01-jun-2022, additional information was received.The information indicated that when the accuracy issue was noted, the trudi probe was being held in the trudi zone.The icon on the trudi system was green.There was no error message on the trudi nav monitor for the device.The device was plugged in after registration (i.E., using the registration probe).The patient tracker was not moved and the patient tracker cable was not under tension in relation to the event.Troubleshooting was performed in that the device was plugged into a different port as well and it was registered twice.The inaccuracy was determined ¿first by the suctions which were probably over 4mm off.Then we proceeded with the probe that was also off by over roughly 2mm.We checked by using anatomical structures including skull base.It showed that it was inferior to skull base even when we could see it was hovering right on it in the scope view.¿ there was no ferromagnetic material placed within the trudi zone.The crosshair did not turn yellow.The emitter pad and the patient did not move.There was no other device¿s shaft in the proximity to the emitter pad¿s transmitter.Based on the additional information received, when the accuracy issue was observed, the trudi probe was being held in the trudi zone and the icon on the trudi system was green.This event has been deemed reportable as a ¿malfunction.¿.

• Brand Name: TRUDI PROBE, 70, 5IN
• Common Device Name: 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 14749157
• Report Number: 3005172759-2022-00009
• Device Sequence Number: 4706040
• Product Code: PGW
• UDI-Device Identifier: 10705031464209
• UDI-Public: 10705031464209
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K193453
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

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 Expiration Date: 02/26/2023
• Device Model Number: TDP0705
• Device Catalogue Number: TDP0705
• Device Lot Number: 210226B-PC
• 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: 06/01/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2021
• 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