Meng Maxwell V
Department of Urology and UCSF Comprehensive Cancer Center, University of California San Francisco, San Francisco, California 94143-0738, USA.
J Endourol. 2006 Dec;20(12):1054-7. doi: 10.1089/end.2006.20.1054.
New technology has played an important role in the proliferation of laparoscopy within urology. A central issue remains meticulous hemostasis, particularly for larger vessels (e.g., renal artery and vein). This paper presents available information regarding failure of the widely utilized nonabsorbable polymer Hem-o-lok clip (Weck Closure Systems, Research Triangle Park, NC), introduced in 1999.
The Food and Drug Administration Center for Devices and Radiological Health maintains a compendium of reports of adverse events involving medical devices (MAUDE). We performed multiple searches of MAUDE using a variety of key words, including Weck, Hem-o-lok, laparoscopy, nephrectomy, and clip.
Within the MAUDE database, we identified 27 reports of problems with the Hem-o-lok clip until July 6, 2005. Of these events, only 1 (4%) involved application during open surgery, with the remainder occurring during laparoscopy. Minimal morbidity resulted from applicator difficulty during laparoscopic cholecystectomy (N = 7; 26%), with one case of open conversion. Forty-eight percent (N = 13) of the failures occurred during urologic laparoscopy; of these, bleeding was the primary problem in 77%. Delayed exploration, immediate open conversion, and death resulted in 38% (N = 5), 8% (N = 1), and 15% (N = 2), respectively. No clear etiology for the events could be found, although in all situations, multiple clips had been applied with apparent initial vessel control intraoperatively.
Reported difficulty with the Hem-o-lok clip occurs primarily during laparoscopic surgery. Cases of failure after laparoscopic nephrectomy require urgent exploration, although it is unclear whether device or user error is the underlying cause. Regardless, care must be taken in securing the renal vessels, surgeons must be educated regarding proper use and techniques, and consideration should be given to using transfixing techniques.
新技术在泌尿外科腹腔镜手术的普及中发挥了重要作用。一个核心问题仍然是精确止血，尤其是对于较大血管（如肾动脉和肾静脉）。本文介绍了有关1999年推出的广泛使用的不可吸收聚合物Hem-o-lok夹（Weck Closure Systems，北卡罗来纳州三角研究园）出现故障的现有信息。
美国食品药品监督管理局器械与放射健康中心维护着一份涉及医疗器械不良事件报告的汇编（MAUDE）。我们使用多种关键词对MAUDE进行了多次搜索，包括Weck、Hem-o-lok、腹腔镜检查、肾切除术和夹子。
在MAUDE数据库中，截至2005年7月6日，我们共识别出27例关于Hem-o-lok夹问题的报告。在这些事件中，只有1例（4%）发生在开放手术应用过程中，其余均发生在腹腔镜手术期间。腹腔镜胆囊切除术中因施夹器困难导致的轻微发病率为7例（26%），其中1例转为开放手术。48%（13例）的故障发生在泌尿外科腹腔镜手术期间；其中，出血是77%的主要问题。延迟探查、立即转为开放手术和死亡分别占38%（5例）、8%（1例）和15%（2例）。尽管在所有情况下，术中最初应用多个夹子时血管控制看似良好，但仍未发现这些事件的明确病因。
报道的Hem-o-lok夹问题主要发生在腹腔镜手术期间。腹腔镜肾切除术后出现故障的病例需要紧急探查，尽管尚不清楚是器械问题还是使用者失误是根本原因。无论如何，在固定肾血管时必须小心，必须对外科医生进行正确使用和技术方面的培训，并且应考虑使用贯穿缝扎技术。
