Initial Experience and Clinical Assessment of the Karl Storz FLEX-XC1 Single-Use Flexible Ureteroscope

Abstract

Study Need and Importance: Single-use flexible ureteroscopes may provide improved performance and cost-effective advantages over traditional reusable devices during procedures with an increased risk of device damage. The Karl Storz FLEX-XC1 is a novel single-use flexible ureteroscope that uses the same videographics platform as its reusable digital counterpart, with potential advantages of improved visual clarity and high-definition resolution. We aimed to evaluate the technical performance of the FLEX-XC1 in real-world clinical use. What We Found: We succesfully completed 93% of procedures using FLEX-XC1. Preoperative upward and downward deflection was < 270 in 21% and 31% of cases, respectively. Three types of intraoperative malfunctions occurred; among these, rotational twisting of deflectable tip was most frequent (13%). Surgeon-rated visual clarity, image quality, and device maneuverability were rated as "very good" or "good" in 100%, 100%, and 97% of cases, respectively. Visual clarity was similar to a benchmark reusable digital device (Figure). No device-specific or general 30-day complications were observed. Limitations: This is a retrospective review of a prospective single-center cohort study. As an initial clinical characterization, this study included a limited number of procedures performed with a single device and was not designed to assess head-to-head comparisons with other devices. While included patients were not randomized, we did choose use cases based on real-world criteria. Interpretation for Patient Care: This clinical evaluation of the FLEX-XC1 single-use flexible ureteroscope confirms subjectively similar visual field clarity, image quality, and maneuverability with reusable digital devices. We observed preoperative incomplete deflection in about one-third of cases. The FLEX-XC1 may be advantageous in prolonged cases where maintaining visual clarity is paramount.