Complications of Novel Radiofrequency Device Use in Rhinology: A MAUDE Analysis.

ABSTRACT

With the widespread adoption of intranasal radiofrequency (RF) devices, our objective was to report national adverse events (AEs) associated with their use. The Food and Drug Administration's Manufacturer and User Facility Device Experience was queried. A total of 24 device-related AEs were reported, 11 (45.8%) for Celon® (Olympus), 3 (12.5%) for Vivaer® (Aerin), 2 (8.3%) for Neuromark® (Neurent), and 8 (33.3%) for Rhinaer® (Aerin). Seven (63.6%) of the Celon®-related complications were related to tissue necrosis (largely user error-related), but 1 (9.1%) episode of pediatric ocular palsy was also reported. Vivaer® complications included synechiae formation, a mucosal perforation, and a case of empty nose syndrome. Of the posterior nasal nerve ablating devices, 9 of 10 AEs were epistaxes, of which 7 (77.8%) required operative intervention. Surgeons should exercise vigilance and tissue-appropriate device settings when utilizing RF devices. Epistaxis and tissue necrosis may occur, as well as more rare, but devastating, complications.