Ent 3.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056481000462), received between Jun 18, 2018 and Jun 18, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Handling 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.

• MalfunctionJun 18, 2018Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem; Use of Device Problem; Improper or Incorrect Procedure or Method; Device Handling Problem

  A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) WAS PERFORMED WITH THE AID OF THE BRAINLAB ENT NAVIGATION SYSTEM VERSION 3.1. THE SURGICAL AREA INCLUDED ANATOMY NEAR THE SKULL BASE. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN SUPINE ORIENTATION AND ATTACHED THE REFERENCE HEADBAND AND REFERENCE ARRAY FOR NAVIGATION. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT WITH REGISTRATION POINTS TAKEN ON THE SKIN OF THE PATIENT TO MATCH THE DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. VERIFIED THE ACCURACY OF THE REGISTRATION ON THE PATIENT'S SKIN WITH ANATOMICAL LANDMARKS, AND JUDGED THE NAVIGATION ACCURACY ACHIEVED LESS THAN OPTIMAL, BUT ACCEPTABLE FOR USE FOR THIS CASE. STARTED THE SURGERY USING AN ENDOSCOPE, CALIBRATED (NON-BRAINLAB) INSTRUMENTS TO THE NAVIGATION TO USE NAVIGATION ONCE BEING NEAR CRITICAL STRUCTURES. NOTED THAT THE INSTRUMENT POSITION DISPLAYED BY NAVIGATION DID NOT MATCH THE IMAGE FROM THE ENDOSCOPE, AND DETERMINED THAT THE NAVIGATION DISPLAY DEVIATED BY CA. 3 MM. CONTINUED THE SURGERY WITH NAVIGATION. WHEN USING AN SHARP-EDGE INSTRUMENT CALIBRATED TO NAVIGATION AS A PROBE, UNINTENTIONALLY THE BASE OF THE PATIENT'S SKULL WAS PERFOR

  Patient problems: Cerebrospinal Fluid Leakage; No Known Impact Or Consequence To Patient

  MAUDE report 7608984 ↗

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