Device failures and patient adverse events from EUS: 26-year FDA MAUDE analysis (2000-2025).

Abstract

EUS has emerged as an essential instrument in the field of gastroenterology, significantly enhancing both diagnostic evaluations and therapeutic procedures. By delivering high-resolution imaging and precise guidance, EUS facilitates a range of interventional techniques. This study sought to examine the adverse events linked to EUS devices following their approval by the US Food and Drug Administration. We performed a retrospective analysis utilizing postmarketing surveillance data sourced from t