Ent 2.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481000486), received between Feb 19, 2020 and Feb 19, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K092467); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2020Use of Device Problem; Use of Device Problem

  WHAT IS THE ISSUE? A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WAS PERFORMED WITH THE AID OF THE DISPLAY BY THE BRAINLAB NAVIGATION SOFTWARE (B)(4) A PREOPERATIVE CT SCAN WAS ACQUIRED 24 DAYS PRIOR TO THE SURGERY, TO USE WITH NAVIGATION. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE POSITION AND ATTACHED THE BRAINLAB REFERENCE HEADBAND AND REFERENCE ARRAY FOR NAVIGATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PREOPERATIVE CT ACQUIRING REGISTRATION POINTS ON THE PATIENT'S SKIN TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION, ACCEPTED THE REGISTRATION TO PROCEED, AND DRAPED THE PATIENT. BEGAN THE SURGERY USING AN ENDOSCOPE, NON-NAVIGATED INSTRUMENTS (DEBRIDER AND FORCEPS), AND THE NAVIGATED BRAINLAB POINTER, WHICH WAS USED FOR GENERAL NAVIGATION GUIDANCE THROUGHOUT THE PROCEDURE. WHILE PERFORMING THE RESECTION IN THE LEFT ETHMOID SINUS, NOTICED THE POSITION OF THE POINTER DISPLAYED BY NAVIGATION DID NOT CORRELATE TO ANATOMICAL LANDMARKS SEEN IN THE ENDOSCOPIC IMAGE, AND DETERMINED TOO MUCH HAD BEEN RESECTED DUE TO THIS DEVIATION OF NAVIGATION. A SECOND SURGEON CAME IN TO CONSULT AND DETE

  Patient problems: Cerebrospinal Fluid Leakage

  MAUDE report 9727567 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092467. One submission often covers many models, so check the product and lot details in each record.

• Z-0056-2021 · Aug 31, 2020 · Terminated
  Ultrasound Navigation Software 1.0 and Ultrasound Integration Software for Cranial/ENT Navigation 3.0.x and 3.1.x - Product Usage: intended to be an intra-operative image guided l
• Z-0598-2016 · Apr 22, 2013 · Terminated
  Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative imag