Image-Guided Surgical Device Failures in Functional Endoscopic Sinus Surgery: A MAUDE Analysis.

Area of Science:

• Otolaryngology
• Medical Device Technology
• Surgical Safety

Background:

• Image-guided surgery (IGS) is integral to functional endoscopic sinus surgery (FESS) for precise anatomic localization.
• Limited data exists on post-market complications specifically related to IGS device usage in FESS.

Purpose of the Study:

• To analyze and characterize post-market complications associated with image-guided surgery (IGS) devices during functional endoscopic sinus surgery (FESS).

Main Methods:

• A retrospective analysis of the US Food and Drug Administration's Manufacturer and User Facility Device Experience database.
• Inclusion of event reports for neurological stereotaxic devices used in IGS specifically for FESS between January 1, 2016, and December 31, 2020.

Main Results:

• 1873 IGS device reports for FESS were analyzed.
• Adverse events occurred in 2.9% of patient reports, with cerebrospinal fluid leakage being most common (45.6%).
• Device malfunctions, primarily imprecision (21.1%), constituted 97.1% of reports.

Conclusions:

• IGS devices are frequently used in FESS, with a low incidence of adverse patient events (<3%) reported between 2016-2020.
• The majority of reported issues involve device malfunctions rather than patient harm.
• Further research into infrequent post-market complications can inform surgeons about clinical risks associated with IGS in FESS.