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	07/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).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.E.1: the name, phone and email address of the initial reporter are not available / reported.H.4: the device manufacture date is not known as the device lot number is not available / not reported.Based on complaint information, the device was not available to be returned for analysis.The device lot number was not available.The manufacturing documentation review could not be performed without the lot number.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, 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.The lot number of the device is not known; therefore, manufacturing documentation review not performed.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device.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 is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2023-00038 and 3005172759-2023-00039.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 revision hybrid functional endoscopic sinus surgery procedure on (b)(6) 2023, when the 0° trudi nav suction device (tdns000z / lot# unknown) was inserted into the back wall of the maxillary sinus, the 0° trudi nav suction device was displayed on the trudi system about 1 cm anteriorly / posteriorly off.The device was replaced with a 70° trudi nav suction device (tdns070z / lot# unknown) and the issue persisted.The instrument adaptor was also replaced without resolution.It was reported that the procedure was completed without resolution; field service engineer (fse) follow-up was requested.There was no report of any negative patient impact.On 04-jul-2023, additional information was received.Related to the 70° trudi nav suction device, the information indicated that the lot number is not available.The device had been reprocessed 20 times; the sterilization method used was not known.When the reported accuracy issue was observed, the bar below the device icon on the trudi system monitor was green.No error message was on the trudi nav monitor.The device was plugged in after registration.The patient tracker was not moved; the patient tracker was not under tension in relation to this event.Computed tomography (ct) image was used as the primary image.The ct scan contains 200+ slices.The information indicated that the inaccuracy was determined ¿inside maxillary at back wall.¿ there was no ferromagnetic material placed within the trudi zone.The crosshairs did not turn yellow.The emitter pad did not move; the patient did not move.No other device¿s shaft was in the proximity of the transmitter of the emitter pad.The trudi system serial number was reported to be (b)(6).Related to the 0° trudi nav suction device, the information indicated that the lot number is not available.The device had been reprocessed 43 times; the sterilization method used was not known.When the reported accuracy issue was observed, the bar below the device icon on the trudi system monitor was green.No error message was on the trudi nav monitor; the device was ¿just inaccurate.¿ the device was plugged in after registration.The patient tracker was not moved; the patient tracker was not under tension in relation to this event.Computed tomography (ct) image was used as the primary image.The ct scan contains 200+ slices.The information indicated that the inaccuracy was determined at the ¿back wall inside the maxillary sinus.¿ there was no ferromagnetic material placed within the trudi zone.The crosshairs did not turn yellow.The emitter pad did not move; the patient did not move.No other device¿s shaft was in the proximity of the transmitter of the emitter pad.The trudi system serial number was reported to be (b)(6).Based on the modified additional information received on 04-jul-2023, the reported issue related to the 0° trudi nav suction device and the 70° trudi nav suction device have been deemed usfda reportable under 21 cfr 803 with a classification of ¿malfunctions.¿.

• 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: 17262971
• Report Number: 3005172759-2023-00039
• Device Sequence Number: 7911799
• Product Code: PGW
• UDI-Device Identifier: 10705031245884
• UDI-Public: 10705031245884
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2023

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
• 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: 07/04/2023
• Initial Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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