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

ABSTRACT:

Objectives

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.

Data sources

MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and MAUDE.

Methods

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 (

SUBMITTER: Clementi EA 

PROVIDER: S-EPMC12706562 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature