Biomedical Engineering and Bioengineering Commons^™

A Novel Approach To Assess Minimally Invasive Surgical Device Failure Utilizing Adverse Event Outcome Severity And Design Complexity., Marie K. Riggs

Electronic Theses and Dissertations

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 …