Mortality related to the use of stapler devices and clip appliers: Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience database

Abstract

BackgroundSurgical staplers and clip appliers are commonly used and have a potential to malfunction, which may result in serious injury or death. These events are self-reported to the Food and Drug Administration and compiled in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. This study characterizes mortality related to surgical stapler and clip applier failure reported in the Food and Drug Administration’s Manufacturer and User Facility Device Experience database. MethodsThe Food and Drug Administration’s Manufacturer and User Facility Device Experience database was reviewed between 1992 and 2016 for medical device reports related to surgical staplers and clip appliers filed under 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. ResultsA 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 postoperatively (N = 516, 76.3%) and were due to infection/sepsis (N = 89, 17.2%) or vascular injuries (N = 110, 21.3%). Intraoperative mortality (N = 79, 11.7%) was primarily due to vascular injuries (N = 73, 92.4%). Device failures resulting in death were noted both intraoperatively (N = 268, 39.6%) and postoperatively (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, 65.4%). In the linear regression analysis, there was a significant increase in the mortality from device failure in the study period after adjusting for annual surgical volume (P < .01). ConclusionMortality related to the use of surgical staplers and clip appliers is increasing. Most deaths occurred postoperatively, and an increased awareness of potential life-threatening complications is warranted when these devices are used.