Adverse Events Associated With Image-Guided Sinus Navigation in Endoscopic Sinus Surgery: A MAUDE Database Analysis.
Francis Reyes OrozcoRuben UlloaMatthew LinMeredith XepoleasMarcus PaolettiXuan LiuKevin T HurPublished in: Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery (2022)
The most commonly reported device- and patient-related adverse events associated with image-guided sinus navigation systems were device nonfunction, imprecision, device sensing difficulties, and CSF leak. When imprecise navigation occurred, there was an increased likelihood of CSF leak and navigation abortion by the surgeon. Health care providers should be mindful of these possible complications when electing to use image-guided sinus navigation during ESS.