Device failures and patient adverse events from EUS: 26-year FDA MAUDE analysis (2000-2025).
PMID: 41938148 ·
Sijia Zhai, Xiaolu Lin, Yiming Song, Zeyu Li, Jingjing Chen, Xiaojie Huang, Zhongge Ji, Qingran Liu, Yufei Xiao, Ruijie Han, Ruitian Zeng, Yuxin Yang, Qingwei Zhang, Wanyin Deng, Xiaobo Li
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
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