Adverse Events Associated With Image-Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis

Area of Science:

• Otolaryngology
• Medical Device Safety

Background:

• Image-guided navigation is increasingly used in endoscopic sinus surgery (ESS).
• Understanding the most common complications associated with this technology is crucial for patient safety.

Purpose of the Study:

• To identify and analyze adverse events related to image-guided navigation systems used in ESS.
• To determine the frequency and types of device-related and patient-related complications.

Main Methods:

• A cross-sectional analysis of the FDA's MAUDE database (2018-2022) was performed.
• Adverse events involving sinus navigation systems in ESS were searched, reviewed, and categorized.

Main Results:

• 1857 adverse events were reported, predominantly device-related (98.8%).
• Common device complications included nonfunctionality (27.9%), imprecision (23.3%), and sensing problems (15.1%).
• Patient complications included cerebrospinal fluid (CSF) leak (60.9%) and intracranial injury (17.4%). Device imprecision was linked to increased CSF leak risk.

Conclusions:

• Device nonfunction, imprecision, sensing issues, and CSF leaks are the most frequent adverse events in image-guided ESS.
• Imprecise navigation significantly elevates the risk of CSF leaks and surgical abortion.
• Healthcare providers must consider these potential complications when utilizing image-guided ESS.