Department of Surgery, University of Pittsburgh Medical Center Mercy, Pittsburgh, PA 15219, USA.
Surg Endosc. 2013 Jan;27(1):86-9. doi: 10.1007/s00464-012-2417-y. Epub 2012 Jul 18.
Laparoscopic instruments are being used with increasing frequency. Our surgeons recently experienced several independent adverse events involving the laparoscopic linear stapler. Although the Food and Drug Administration maintains a Manufacturer and User Facility Device Experience (MAUDE) database to track such voluntary reports, many events are not reported and the true incidence of adverse events is unknown. We attempted to determine how frequently minimally invasive surgeons have experienced technical problems with a laparoscopic stapler.
Following IRB approval, we electronically distributed an anonymous 10-question survey to the 124 minimally invasive program directors listed in the Fellowship Council database. The questions focused on personal or peer experience with laparoscopic stapler malfunction, frequency and type of malfunction, device manufacturer, whether the operation was altered, and root cause analysis of the event.
Forty-four of the 124 program directors (35%) completed the survey. The majority reported personal or peer experience (86%) with a linear stapler not releasing (66%) or not firing (73%) after application, with 27% of the respondents noting that this occurred three or more times. The malfunction was not related to type of load, straight (23%) or reticulating (32%) model, or manufacturer (Ethicon 30%, Covidien 36%). One quarter of the respondents noted that the malfunction caused them to significantly alter their operative procedure, and 30% reported that they received no helpful feedback from the manufacturer despite contacting it.
Most minimally invasive surgeons have experienced laparoscopic linear stapler malfunction and 25% have had to significantly alter the planned operative procedure due to the malfunction.
腹腔镜器械的使用频率越来越高。最近，我们的外科医生遇到了几起涉及腹腔镜线性吻合器的独立不良事件。尽管食品和药物管理局维护了一个制造商和用户设施设备经验（MAUDE）数据库来跟踪此类自愿报告，但许多事件并未报告，不良事件的真实发生率尚不清楚。我们试图确定微创外科医生使用腹腔镜吻合器经历技术问题的频率。
在获得机构审查委员会批准后，我们通过电子邮件向 Fellowship Council 数据库中列出的 124 名微创项目主任分发了一份匿名的 10 个问题的调查。这些问题集中在个人或同行经历腹腔镜吻合器故障、故障频率和类型、设备制造商、手术是否改变以及事件的根本原因分析上。
124 名项目主任中有 44 名（35%）完成了调查。大多数人报告了个人或同行的经历，即线性吻合器在应用后未释放（66%）或未触发（73%），27%的受访者指出这种情况发生了三次或更多次。故障与负载类型无关，直型（23%）或网孔型（32%）模型或制造商（Ethicon 30%，Covidien 36%）无关。四分之一的受访者指出，故障导致他们显著改变了手术程序，30%的受访者表示，尽管联系了制造商，但没有收到有用的反馈。
大多数微创外科医生都经历过腹腔镜线性吻合器故障，25%的人因故障不得不显著改变计划的手术程序。
