Adverse Events Associated With Laser Use in the Upper Airway. (May 2021)

• Record Type: Journal Article
• Authors: Tong, Jane Y.; Pasick, Luke J.; Benito, Daniel A.; Sataloff, Robert T.
• Is Part Of: Otolaryngology--head and neck surgery. Volume 164:Number 5(2021)
• Page Start: 911
• Page End: 917
• Publication Date: 2021-05
• Subjects: MAUDE -- adverse event -- quality -- patient safety -- airway -- laryngology -- laser -- PS/QI; Head -- Surgery -- Periodicals; Neck -- Surgery -- Periodicals; Otolaryngology -- Periodicals; 617.51
• DOI: 10.1177/0194599820938743
• Languages: English
• ISSNs: 0194-5998

Abstract

Objective: Surgical lasers are used extensively in head and neck surgery. Laser use in the upper airway offers many advantages but also presents risks to patients and operators that are not reported comprehensively. This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to laser use in the upper airway. Methods: The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was queried for reports of surgical laser adverse events from January 2010 to March 2020. Data were extracted from reports pertaining to the upper airway. Results: Sixty-two reports involving upper airway laser use in an operating room were identified, from which 95 events were extracted. Of these, 40 (42.1%) were adverse events to patients, 2 (2.1%) adverse events to operators, and 53 (55.8%) device malfunctions. Dislodgement of laser fiber in the airway (23 [57.5%]), burn (8 [20%]), and scar (5 [12.5%]) were the most common adverse events to patients. Two incidents of eye exposure through unfiltered microscope lenses were the only adverse events to operators. Fiber break (26 [49.1%]) and flare (12 [22.6%]) were the most common device malfunctions. Discussion: Surgical lasers have demonstrated utility in head and neck surgery but are associated with risks. This study discusses adverse events and device malfunctions associated with airway laser surgery and emphasizes shortcomings in current reporting. Implications for Practice: Standardized reporting and multi-institutional research are needed to better understand adverse events related to surgical laser use and to allow accurate estimation of their prevalence.