Patel Neel H, Schulman Ariel A, Bloom Jonathan B, Uppaluri Nikil, Phillips John L, Konno Sensuke, Choudhury Muhammad, Eshghi Majid
1 Department of Urology, New York Medical College , Valhalla, New York.
2 Division of Urology, Department of Surgery Duke University Medical Center , Durham, North Carolina.
J Endourol. 2017 Oct;31(10):1007-1011. doi: 10.1089/end.2017.0343.
Percutaneous nephrolithotomy (PCNL) is an established technique for removal of large stones from the upper urinary tract. It is a complex multistep procedure requiring several classes of instruments that are subject to operator misuse and device malfunction. We report device-related adverse events during PCNL from the Manufacturer and User Facility Device Experience (MAUDE) database using a recently developed standardized classification system.
The MAUDE database was queried for "percutaneous nephrolithotomy" from 2006 to 2016. The circumstances and patient complications associated with classes of devices used during PCNL were identified. We then utilized a novel MAUDE classification system to categorize clinical events. Logistic regression analysis was performed to identify associations between device classes and severe adverse events.
A total of 218 device-related events were reported. The most common classes included: lithotripter 53 (24.3%), wires 43 (19.7%), balloon dilators 30 (13.8%), and occlusion balloons 28 (12.8%). Reported patient complications included need for a second procedure 12 (28.6%), bleeding 8 (19.0%), retained fragments 7 (16.7%), prolonged procedure 4 (9.5%), ureteral injury 2 (4.8%), and conversion to an open procedure 3 (7.1%). Using a MAUDE classification system, 176 complications (81%) were Level I (mild/none), 26 (12%) were Level II (moderate), 15 (7%) were Level III (severe), and 1 (0.5%) was Level IV (life threatening). On univariate analysis, balloon dilators had the highest risk of Level II-IV complications compared with the other device classes [odds ratio: 4.33, confidence interval: 1.978, 9.493, p < 0.001]. The device was evaluated by the manufacturer in 93 (42.7%) cases, with 54.8% of reviewed cases listing the source of malfunction as misuse by the operator.
PCNL is subject to a wide range of device-related adverse events. A MAUDE classification system is useful for standardized, clinically-relevant reporting of events. Our findings highlight the importance of proper surgeon training with devices to maximize efficiency and decrease harm.
经皮肾镜取石术（PCNL）是一种用于清除上尿路大结石的成熟技术。它是一个复杂的多步骤手术，需要几类器械，而这些器械可能会被操作者误用或出现设备故障。我们使用最近开发的标准化分类系统，从制造商和用户设施设备经验（MAUDE）数据库中报告PCNL期间与设备相关的不良事件。
查询MAUDE数据库中2006年至2016年期间的“经皮肾镜取石术”。确定与PCNL期间使用的各类设备相关的情况和患者并发症。然后我们使用一种新的MAUDE分类系统对临床事件进行分类。进行逻辑回归分析以确定设备类别与严重不良事件之间的关联。
共报告了218起与设备相关的事件。最常见的类别包括：碎石机53起（24.3%）、导丝43起（19.7%）、球囊扩张器30起（13.8%）和阻塞球囊28起（12.8%）。报告的患者并发症包括需要进行二次手术12例（28.6%）、出血8例（19.0%）、残留碎片7例（16.7%）、手术时间延长4例（9.5%）、输尿管损伤2例（4.8%）以及转为开放手术3例（7.1%）。使用MAUDE分类系统，176例并发症（81%）为I级（轻度/无），26例（12%）为II级（中度），15例（7%）为III级（重度），1例（0.5%）为IV级（危及生命）。单因素分析显示，与其他设备类别相比，球囊扩张器发生II - IV级并发症的风险最高[比值比：4.33，置信区间：1.978，9.493，p < 0.001]。制造商对93例（42.7%）病例中的设备进行了评估，在审查的病例中，54.8%将故障原因列为操作者误用。
PCNL会出现多种与设备相关的不良事件。MAUDE分类系统有助于对事件进行标准化且与临床相关的报告。我们的研究结果强调了外科医生对设备进行适当培训以提高效率和减少伤害的重要性。
