Pediatric Complications of Automated Tympanostomy Tube Systems: MAUDE Analysis and Systematic Review.

Abstract

This study evaluates complications associated with automated tympanostomy tube delivery systems (TDS) in pediatric patients through a systematic review and analysis of the Manufacturer and User Facility Device Experience (MAUDE) database. MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and MAUDE. A systematic review following PRISMA guidelines identified studies on automated TDS, while the MAUDE database was queried using the product class "tympanostomy tube delivery system with drug" and relevant manufacturers. Primary outcomes included intra- and post-procedural complications, while secondary outcomes assessed procedural success and escalation to general anesthesia (GA) or total intravenous anesthesia (TIVA) in the operating room (OR). Intraprocedural complications occurred in 8.2% of cases. The most frequently cited complication in the literature was excessive movement or behavioral intolerance (56%), while inadequate anesthesia (38%) was the leading intraprocedural issue in MAUDE reports. The average procedural success rate was 91%, with 3.2% requiring OR escalation. Postprocedural complications occurred in 33% of cases, with tube occlusion (36%) and reluctance to undergo ear examinations (30%) as the most common short-term events. Long-term complications included otitis media with otorrhea (32%) and otitis media (25%). While TDS were designed to streamline in-office care, their effectiveness remains uncertain due to challenges in achieving adequate immobility and anesthesia in awake pediatric patients. Although complication rates appear comparable to traditional tympanostomy tubes, some reports highlight concerns regarding procedural distress. Further research is needed to refine patient selection, optimize anesthesia protocols, and assess long-term outcomes to determine their role in pediatric otolaryngology. N/A.