Introduction: Surgical staplers and clip appliers are commonly used. These devices have a potential to malfunction, which may result in serious injury or death. This study characterizes mortality related to surgical stapler and clip applier failure reported in the FDA’s MAUDE database.
Methods: The FDA’s MAUDE database was reviewed between 1992 and 2016 based on the following product codes: GAG, FZP, GDO, GDW, KOG and GCJ. Adverse events including death and the type of device failure were reviewed. Temporal trends in reported deaths related to device failure were analyzed and the Healthcare Cost and Utilization Project database was used to adjust for annual surgical case volume using linear regression analysis. We identified temporal trends in mortality associated with surgical stapler and clip applier malfunction.
Results: A total of 75,415 malfunctions, 21,115 injuries, and 676 deaths were associated with the use of surgical stapler and clip applier devices. Most deaths occurred post-operatively (N=516, 76.3%) and were due to infection/sepsis (N=89, 17.2%) or vascular injuries (N= 110, 21.3%). Intra-operative mortality (N=79, 11.69%) was primarily due to vascular injuries (N=73, 92.4%). Device failures resulting in death were recognized both intra-operatively (N=268, 39.6%) and post-operatively (N=325, 48.1%). In post hoc root cause analysis, a surgical stapler and clip applier device problem was the most common attributed cause of death (N=238, 65%). In the linear regression analysis, there was a significant increase in the mortality from device failure in recent years after adjusting for annual surgical volume (p < 0.01).
Conclusions: Mortality related to the use of surgical stapler and clip applier is increasing. Most deaths occurred post operatively, and an increased awareness of potential life threatening complications is warranted when these devices are utilized.
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