Objective: To evaluate retrospectively the incidence of complications during Fiberoptic Endoscopic Evaluation of Swallowing (FEES) in 5680 examinations. Patients and Methods: 5680 patients were evaluated at the Department of Otorhinolaryngology, Audiology and Phoniatrics of Pisa University Hospital between January 2014 and December 2018, involving both inpatients and outpatients. Most common comorbidities included neurological pathologies such as stroke (11.8%), neurodegenerative diseases (28.9%) and a history of previous head and neck surgery (24.6%). The evaluation was conducted by clinicians with experience in swallowing for a minimum of 10 years with the assistance of one or more speech language pathologists. Results: In all patients studied the endoscope insertion was tolerated and it was possible to visualize the pharyngo-laryngeal structures. Most patients reported discomfort In a minority of patients, complications were recorded, such as anterior epistaxis, posterior epistaxis, vasovagal crises and laryngospasm. Laryngospasm was recorded in patients affected by Amyotrophic Lateral Sclerosis (ALS). Multivariate binary logistic regression showed that discomfort, chronic gastrointestinal diseases, neurodegenerative diseases and brain tumors were risk factors associated with minor complications. Conclusions: FEES proved to be easy to perform, well tolerated by the patients and cost-effective. It can be performed at the patient’s bedside and it is characterized by low rate of complications. As a matter of fact, normally only discomfort, gagging and/or vomit are reported. Only rarely complications occur, such as anterior or posterior epistaxis episodes or vasovagal crises, but these are still easily managed. Exceptionally, more severe complications are reported: adverse drug reactions to substances such as blue dye (methylene blue) and local anesthetics (not used in our protocol), and laryngospasm.

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