Endoscopic ultrasound · 2026
Device failures and patient adverse events from EUS: 26-year FDA MAUDE analysis (2000-2025).
СтатьяНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
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Ошибки и ограничения
История · было → стало
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Zhai Sijia, Lin Xiaolu, Song Yiming, Li Zeyu, Chen Jingjing, Huang Xiaojie, Ji Zhongge, Liu Qingran, Xiao Yufei, Han Ruijie, Zeng Ruitian, Yang Yuxin, Zhang Qingwei, Deng Wanyin, Li Xiaobo
Аннотация
BACKGROUND AND OBJECTIVES: 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.
METHODS: We performed a retrospective analysis utilizing postmarketing surveillance data sourced from the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. This analysis encompasses data from January 1, 2000, to August 31, 2025.
RESULTS: A total of 7608 reports detailing 8778 device-related issues and 7875 patient complications were analyzed. The most commonly reported device-related problems included peeling or delamination, with 1251 reports, followed by device breakage at 837 reports, microbial contamination at 781 reports, and inadequate cleaning at 704 reports. In terms of patient-related complications, the most frequently reported adverse events were blood loss (73 reports), tissue perforation (44 reports), and pancreatitis (32 reports). Furthermore, there were 743 documented instances of microbial contamination in EUS devices, with Coagulase-negative staphylococci being identified as the predominant pathogen, appearing in 151 reports.
CONCLUSIONS: The examination of the MAUDE database reveals significant device and patient-related adverse events that endoscopists must consider during EUS procedures. Continuous postmarketing surveillance and the evaluation of real-world data are crucial for determining the safety and effectiveness of endoscopic devices, which in turn enhances patient outcomes.
METHODS: We performed a retrospective analysis utilizing postmarketing surveillance data sourced from the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. This analysis encompasses data from January 1, 2000, to August 31, 2025.
RESULTS: A total of 7608 reports detailing 8778 device-related issues and 7875 patient complications were analyzed. The most commonly reported device-related problems included peeling or delamination, with 1251 reports, followed by device breakage at 837 reports, microbial contamination at 781 reports, and inadequate cleaning at 704 reports. In terms of patient-related complications, the most frequently reported adverse events were blood loss (73 reports), tissue perforation (44 reports), and pancreatitis (32 reports). Furthermore, there were 743 documented instances of microbial contamination in EUS devices, with Coagulase-negative staphylococci being identified as the predominant pathogen, appearing in 151 reports.
CONCLUSIONS: The examination of the MAUDE database reveals significant device and patient-related adverse events that endoscopists must consider during EUS procedures. Continuous postmarketing surveillance and the evaluation of real-world data are crucial for determining the safety and effectiveness of endoscopic devices, which in turn enhances patient outcomes.