Telbany Ahmed, Mohamed Islam, Alchirazi Khaled Alsabbagh, Hamid Osama, Parasher Gulshan
Department of Gastroenterology & Hepatology, University of New Mexico, Albuquerque, New Mexico, USA.
Department of Internal Medicine, University of Missouri Kansas City, Kansas City, Missouri, USA.
Gastrointest Endosc. 2025 May;101(5):965-969. doi: 10.1016/j.gie.2024.10.001. Epub 2024 Oct 4.
The Ovesco clip system (Tübingen, Germany), including the over-the-scope clip and full-thickness resection device, has demonstrated efficacy in managing various GI pathologies. However, real-world data on device malfunctions and patient adverse events are limited. This study aimed to analyze adverse events associated with Ovesco clips and cutters reported to the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.
The MAUDE database was searched for reports related to Ovesco clips and cutters from January 1, 2007, to August 30, 2024. Event date, device type and model, manufacturer, event type, device problem, and patient adverse events were extracted. Descriptive statistics were used to summarize the findings.
Forty-two reports were identified, with 41 involving Ovesco clips and 1 involving an Ovesco cutter. The most common device problem for Ovesco clips was failure to deploy (61.0%), followed by unintended deployment or misfiring (17.1%). GI perforation was the most frequently reported patient adverse event (60%). The Ovesco cutter report described device component breakage and foreign body retention. No clear trends in adverse event reporting were observed over the study period.
Ovesco clips and cutters are associated with potential device malfunctions and patient adverse events, particularly GI perforation. The findings highlight the need for careful patient selection, meticulous technique, and close postprocedural monitoring. Collaborative efforts among stakeholders are essential to optimize device safety and efficacy. Continued postmarketing surveillance and real-world data analysis are crucial for monitoring the performance of endoscopic devices and improving patient outcomes.
Ovesco夹系统（德国图宾根），包括套扎夹和全层切除装置，已证明在处理各种胃肠道病变方面有效。然而，关于设备故障和患者不良事件的真实世界数据有限。本研究旨在分析向美国食品药品监督管理局制造商和用户设施设备经验（MAUDE）数据库报告的与Ovesco夹和切割器相关的不良事件。
检索MAUDE数据库中2007年1月1日至2024年8月30日期间与Ovesco夹和切割器相关的报告。提取事件日期、设备类型和型号、制造商、事件类型、设备问题和患者不良事件。采用描述性统计方法总结研究结果。
共识别出42份报告，其中41份涉及Ovesco夹，1份涉及Ovesco切割器。Ovesco夹最常见的设备问题是未能展开（61.0%），其次是意外展开或误触发（17.1%）。胃肠道穿孔是最常报告的患者不良事件（60%）。Ovesco切割器的报告描述了设备部件断裂和异物残留。在研究期间未观察到不良事件报告的明显趋势。
Ovesco夹和切割器与潜在的设备故障和患者不良事件相关，尤其是胃肠道穿孔。研究结果强调了谨慎选择患者、细致操作技术和术后密切监测的必要性。利益相关者之间的合作对于优化设备安全性和有效性至关重要。持续的上市后监测和真实世界数据分析对于监测内镜设备的性能和改善患者预后至关重要。
