MAUDE Adverse Event Report: ACCLARENT, INC. TRUDI SUCTION, 0 - 1PK; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number TDNS000Z

Device Problems Incorrect Interpretation of Signal (1543); Communication or Transmission Problem (2896)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a primary hybrid functional endoscopic sinus surgery procedure on (b)(6)2023, accuracy was off by about 5-6mm.The reporter stated that the inaccuracy occurred on three trudi navigation suction devices.One of these three devices also had an ¿error code¿.The devices with the alleged product malfunction were a trudi suction, 0 - 1pk (tdns000z, (b)(6) trudi suction, 0 - 1pk (tdns000z, lot unknown) and a trudi suction, 70 - 1pk (tdns070z, lot unknown).Additional information was received indicating that the physician performed the registration.The customer confirmed accuracy was performed by using the registration probe after registration process was completed.The customer confirmed accuracy known landmarks in endoscopic visualization inside the nasal cavity.The inaccuracy was determined when confirming accuracy on known anatomy landmarks, unicante, max wall.The event occurred at the start of the case.The inaccuracy was noticed by using the registration probe with instrumentation.They plugged in the devices after registration.When the accuracy issue was observed, the icon on the trudi nav system was green.Ct scan was performed via axial view.There were no noticeable defects to the ct scanned image.Sterilization method was used as per the instructions for use (ifu).There was no error message on the trudi navigation monitor for the device.The devices were reprocessed 10 times.The physician was frustrated and decided to continue the procedure with the issue persisting.The caller is requesting documentation only.There was no death or serious injury that occurred due to the use of the products.There was no report of patient requiring medical intervention as a result the alleged product issue.A spinplus navigation balloon sinuplasty system (rsp0616mfsn / lot# unknown) was repoted as having a loss of signal.

Manufacturer Narrative

Product complaint (b)(4).Section d4 expiration date: not available at time of report.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Section h3 - 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.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.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3005172759-2024-00002 and 3005172759-2024-00003.

Manufacturer Narrative

Product complaint # (b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

Manufacturer Narrative

Product complaint #
=
> (b)(4) updated sections on this medwatch: b4, g3, g6, h2, h3, h6 and h10.The product was returned to acclarent for evaluation.A non-sterile suction 0° device was returned with the serial number (b)(6).Upon arrival, a visual inspection was performed, and no damages or abnormalities were observed in the device.The device calibration check, connectivity, response testing, and electrical testing were performed on the device after passing a visual inspection.The calibration of the device was checked on the magnetic calibration system (magcs) and it passed the calibration check.The device failed to meet the spec for isolation between the shield and eeprom io >1 mo and the spec for isolation between the shield and eeprom gnd >1 mo.Then the device was connected successfully to the trudi navigation system and was responsive.A manufacturing record evaluation was performed, and no non-conformances related to the complaint were found during the review.The device has passed visual inspection, magcs calibration check, trudi connectivity, and response test but failed electrical testing.Because failure to meet electrical specifications can cause the device to not function properly, the accuracy issue is confirmed.It should be noted that product failure is multifactorial.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no capa activity is required at this time.As part of acclarent¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: TRUDI SUCTION, 0 - 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 ; 3035526892
• MDR Report Key: 18427684
• MDR Text Key: 332602450
• Report Number: 3005172759-2024-00001
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TDNS000Z
• Device Lot Number: 2207120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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
• Treatment: RELIEVA SPINPLUS BALLOON SINUPLASTY SYSTEM; TRUDI SUCTION, 0 - 1PK; TRUDI SUCTION, 70 - 1PK