Unanticipated Serious Adverse Device Effect (USADE)

A Serious Adverse Device Effect which by its nature, incidence, severity, or outcome has not been identified in the current version of the risk analysis report. An Anticipated Serious Adverse Device Effect (ASADE) is an effect which by its nature, incidence, severity, or outcome has been identified in the risk analysis report. This includes unanticipated procedure-related Serious Adverse Events that are occurring during the study procedure that is unrelated to any malfunction or misuse of the investigational medical device.