内镜超视镜剪切器和切割器的不良事件:制造商和用户设施设备经验数据库分析
Ahmed Telbany1, Islam Mohamed2, Khaled Alsabbagh Alchirazi3
1Department of Gastroenterology & Hepatology, University of New Mexico, Albuquerque, New Mexico, USA.
Gastrointestinal endoscopy
|October 5, 2024
概括
奥维斯科剪贴和切割刀可能会出现故障,导致胃肠道穿孔. 对不良事件的分析强调了需要仔细使用和监测这些内镜装置的必要性.
科学领域:
- 胃肠病学 胃肠病学
- 医疗器械安全 医疗器械安全
- 内镜手术 进行内镜手术
背景情况:
- 奥维斯科剪贴系统用于肠道病理.
- 关于Ovesco设备故障和不良事件的现实数据有限.
研究的目的:
- 分析与Ovesco剪贴和切割刀相关的不良事件.
- 使用来自美国食品和药物管理局制造商和用户设施设备体验 (MAUDE) 数据库的数据.
主要方法:
- 在MAUDE数据库中搜索了Ovesco的剪贴和切割报告 (2007-2024年).
- 提取了事件类型,设备问题和患者不良事件的数据.
- 使用描述性统计数据总结发现.
主要成果:
- 确定了42个报告 (41个Ovesco剪辑,1个切割器).
- 最常见的剪辑问题:无法部署 (61.0%).
- 最常见的不良事件:肠道穿孔 (60%).
结论:
- 奥维斯科设备有潜在的故障和风险,包括胃肠道穿孔.
- 强调需要仔细选择患者,技术和监测.
- 强调推销后监测对设备安全的重要性.
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