Analysis of Reported Adverse Events Associated With the Use of Functional Lumen Imaging Probe Devices in the Esophagus and Stomach: An FDA MAUDE Database Study

F. Jaber, W. Johnson, N. Wilson, Saqr Alsakarneh, Mouhand F. H. Mohamed, K. Ahmed, Nicole Patel, B. Hanson, Mohamed Abdallah, M. Bilal
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引用次数: 0

Abstract

The endoscopic Functional Lumen Imaging Probe (FLIP) devices are used to evaluate pressure changes, diameter, and volume of the esophagus. We used the FDA’s MAUDE database to collect post-marketing surveillance data on these devices from January 2009 to September 2022. Forty-Five device-related events and thirty-six patient-related adverse events were analyzed. The most common device issue for the diagnostic FLIP device was therapeutic/diagnostic failure (n = 6), while the most frequent issue with the therapeutic FLIP device was adverse events without an identified device or use problem (n = 11). Patient-related adverse events were extremely rare with the diagnostic FLIP and the most common patient-related adverse event with the therapeutic FLIP was perforation (n = 11). Endoscopists need to be mindful of these potential technical issues and adverse events while using these devices.
与食道和胃使用功能性管腔成像探头装置相关的不良事件分析:FDA MAUDE数据库研究
内镜下功能管腔成像探针(FLIP)装置用于评估食管的压力变化、直径和体积。我们使用FDA的MAUDE数据库收集2009年1月至2022年9月期间这些器械的上市后监测数据。分析了45个器械相关事件和36个患者相关不良事件。诊断性FLIP设备最常见的设备问题是治疗/诊断失败(n = 6),而治疗性FLIP设备最常见的问题是没有确定设备或使用问题的不良事件(n = 11)。诊断性FLIP的患者相关不良事件极为罕见,治疗性FLIP最常见的患者相关不良事件是穿孔(n = 11)。内窥镜医师在使用这些设备时需要注意这些潜在的技术问题和不良事件。
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