Department of Urologic Surgery, University of Minnesota, Minneapolis, Minnesota, USA.
J Urol. 2011 Jan;185(1):179-83. doi: 10.1016/j.juro.2010.08.091. Epub 2010 Nov 13.
We categorized trends in failure of the stone baskets as reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience database.
We queried the online database using the code for stone baskets (FFL) from January 1996 to December 2009. Variables extracted were the type of basket, malfunction and treatment, and patient outcome.
We identified 556 adverse events related to stone baskets. The device configuration was tipped in 48% of cases, tipless in 36%, forceps in 8% and the Stone Cone™ in 8%. Malfunction type included detachment of a portion of the basket in 49% of cases, breakage without detachment in 39% and inability to withdraw the basket in 12%. Compared to the early period studied (1996 to 2004) there was a 3-fold increase in adverse events from 2005 to 2007 and a 6-fold increase from 2008 to 2009. Of adverse events 79% and 11% were managed by endoscopy and open surgery, respectively. Of the patients 42 experienced serious complications requiring major surgery, including ureteral reconstruction in 7, reimplantation in 4 and nephrectomy in 7.
With the increased use of stone baskets in the upper collecting system the number of adverse events has increased. Urologists should remain vigilant to prevent, recognize and manage these events.
我们对美国食品和药物管理局制造商和用户设施设备体验数据库中报告的结石篮失败趋势进行了分类。
我们使用结石篮的代码（FFL）从 1996 年 1 月至 2009 年 12 月查询了在线数据库。提取的变量包括篮筐类型、故障和治疗以及患者结果。
我们发现了 556 例与结石篮相关的不良事件。设备配置在 48%的病例中为尖端，36%为无尖端，8%为钳子，8%为 Stone Cone™。故障类型包括篮筐部分脱落 49%，无脱落断裂 39%，无法撤出篮筐 12%。与研究早期（1996 年至 2004 年）相比，2005 年至 2007 年不良事件增加了 3 倍，2008 年至 2009 年增加了 6 倍。在不良事件中，79%和 11%分别通过内镜和开放手术进行管理。在这些患者中，有 42 人经历了严重并发症，需要进行重大手术，包括 7 例输尿管重建、4 例再植入和 7 例肾切除术。
随着上尿路结石篮的广泛应用，不良事件的数量有所增加。泌尿科医生应保持警惕，以预防、识别和处理这些事件。
