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

INTRODUCTION

The Karl Storz FLEX-XC1 is a novel single-use flexible ureteroscope that uses the same videographics platform as its reusable digital counterpart. We evaluated the technical performance of the FLEX-XC1 in its initial clinical use.

METHODS

We reviewed a series of consecutive ureteroscopy procedures performed by 2 endourologists using the FLEX-XC1 for indications for which we typically use a single-use device: total stone burden > 15 mm or > 10 mm in the lower pole, anticipated case duration > 60 minutes, bilateral procedure, or upper tract urothelial cancer procedures. We assessed device tip deflection, intraoperative mechanical failure, and clinical outcomes for each case. Surgeons rated visual clarity, image quality, and maneuverability on a 1 to 5 Likert scale.

RESULTS

Of 29 procedures using FLEX-XC1, 27 (93%) were successfully completed. Preoperative upward deflection was < 270° in 6 (21%) cases, and downward deflection was < 270° in 9 (31%) cases. Three types of intraoperative malfunctions occurred: rotational twisting of deflectable tip (4 cases, 13%), device not advancing through distal ureter (1 case, 3%), and working channel not accommodating a 365-μm laser (1 case, 3%). Visual clarity, image quality, and maneuverability were rated as 5 "very good" or 4 "good" in 100%, 100%, and 97% of cases, respectively. No device-specific or general 30-day complications were observed.

CONCLUSIONS

The FLEX-XC1 showed comparable image quality and maneuverability to reusable digital devices. We observed incomplete deflection in up to 31% of cases and mechanical failure in 2 cases. The FLEX-XC1 may be advantageous in prolonged cases where maintaining visual clarity is paramount.