Note: If you need help accessing information in different file formats, see That’s why CCH is now offering the ACCLARENT TruDi™ Nav System, an electromagnetic navigation system for ear, nose and throat (ENT) surgeries. Manufacturer¿s ref. The healthcare professional reported that during a primary balloon sinuplasty procedure targeting the sphenoid sinus, the trudi suction device (tdns000z / s/n: (b)(4) / lot# unk) was not in its accurate location; it was off by more than 2mm. 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.

No: (b)(4). ACCLARENT, INC. TRUDI SUCTION, 0 - 1PK TRUDI NAV SUCTION, 0: Back to Search Results: Catalog Number TDNS000Z: Device Problem Calibration Problem: Event Date 07/10/2019: Event Type Malfunction Manufacturer Narrative Manufacturer¿s ref. Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English, No Consequences Or Impact To Patient (2199), Instructions for Downloading Viewers and Players. The associated manufacturer report numbers are: 3005172759-2019-00121. Acclarent’s TruDi has been a massive failure to date....proported “best of class track” tip accuracy has been anything but as accurate as the market leader, Medtronic. The physician was able to connect to a new suction device. It greatly increases the accuracy of the balloon placement. No: (b)(4). This issue was not noticed in previous uses of the device. Additional information will be submitted within 30 days of receipt.

The name, phone and email address of the initial reporter are not available / reported.

Trudi is the greatest advance in balloon sinuplasty in years. When the loss of accuracy was observed, the icon on the trudi system was green.

ACCLARENT TruDi™ Nav System Columbus Community Hospital is committed to providing the latest technology. Information regarding patient identifier, weight, race, ethnicity, and medical history were not provided. Acclarent Inc. 33 Technology Drive Irvine, California 92618 Re: K192397 Trade/Device Name: TruDi Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: PGW Dated: December 31, 2019 Received: January 2, 2020 Dear David Locke: We have reviewed your Section 510(k) premarket notification of intent to market the … The device does not have an expiration date as it is a non-sterile re-usable device. The procedure was completed without any patient injury. This is one of 2 products involved with the reported complaint. Acclarent said that the first commercial procedures were performed with the device on April 16, after having previously won FDA 510(k) clearance.

The device was initially accurate and then later appeared to be inaccurate.

Acclarent, Inc., part of the Johnson & Johnson Medical Devices Companies and a leader in developing minimally-invasive Ear, Nose & Throat (ENT) technologies, announced the U.S. commercial launch of TruDi, a real-time, three-dimensional (3D) navigation system for ENT procedures performed in the operating room and surgeon office. The device lot number is not available / not reported. There was no issue noted during the set up and registration of the suction tool. It was reported that the suction device has been reprocessed less than 5 times. Instructions for Downloading Viewers and Players. The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report. Information regarding patient identifier, weight, race, ethnicity, and medical history were not provided.

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