A novel approach to assess minimally invasive surgical device failure utilizing adverse event outcome severity and design complexity.

Medical device failure and misuse have the potential to cause serious injury and death. Given the intricate nature of the instruments utilized specifically in minimally invasive surgery (MIS), users and manufacturers of surgical devices share a responsibility in preventing user error and device failure. A novel approach was presented for the evaluation of minimally invasive device failures, which involved assessing the severity of adverse event outcomes associated with the failures modes and investigating aspects of the devices’ design that may contribute to failure. The goals of this research were to 1) characterize the design attributes, failure modes, and adverse events associated with minimally invasive surgical devices and 2) describe the relationship between minimally invasive surgical device design complexity and the severity of adverse events. The types of failure modes, phases of operation in which failure occurs, severity of adverse event outcomes, and design complexity associated with four minimally invasive surgical devices were determined. An association was shown to exist between phases of surgical device operation and the severity of outcomes that occur in each phase (p \u3c 0.05). Across both device types, the majority of failure occurred during execution of the devices’ main function which involved securing and transecting tissue. The least amount of failures occurred during the results and post-op phase of operation; however, the failures that occurred during this phase resulted in the highest average outcome severity. The endoscopic staplers assessed resulted in overall higher average outcome severities relative to that of the tissue sealers. The methods employed are the first to evaluate medical device design, function, and failure outcomes from a complexity perspective. While statistical conclusions regarding the overall research goal could not be drawn, heuristic methods support development of the approach presented. The work herein assists the enhancement of risk awareness and prevention techniques and serves as a contribution to filling the knowledge gap regarding device use and failure outcomes. Bridging the gap between surgeons and engineers is crucial to the successful implementation and evaluation of new technology in the operating room, which was an essential component of this research