Safety Profile and Adverse Events of High-Power Laser Systems: An Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database

Abstract

Background:

With recent technological advances, high-power laser systems with maximum power output of 150 W have shown advantages over standard-power laser systems in urological procedures. Our study aims to utilize the Manufacturer and User Facility Device Experience (MAUDE) database to examine the real-world safety profile of high-power laser systems.

Methods:

We searched the MAUDE database for reports on high-power laser systems, including Holmium Yttrium-Aluminum-Garnet (YAG), Thulium fiber laser, and Thulium YAG, from 1993 to 2024. Complications were identified and categorized.

Results:

A total of 1294 reports were found on initial search, of which 273 reports pertaining to high-power laser systems met inclusion criteria. We found 205 reports involving Holmium YAG, with 138 reports for laser lithotripsy and 67 for laser enucleation of the prostate. Most Holmium YAG complications were Clavien Dindo grade I and II events (n = 170, 92.9%), with renal colic (n = 38) and fever (n = 34) being the most frequently reported. There were 68 reports involving Thulium fiber laser systems, 66 of which were for laser lithotripsy. These reports consisted of a high number of grade III and IV postoperative events (n = 24, 85.7%), with ureteral stricture being the most common complication (n = 17). Ten ureteral strictures took place between first clinical use in June 2020 and June 2021, while 6 occurred between July 2021 and October 2024. No Thulium YAG reports met inclusion criteria.

Conclusions:

Our analysis showed minor adverse events associated with high-power Holmium YAG laser systems, indicating an overall strong safety profile. We also found that Thulium fiber laser systems showed a high number of CD grade III and IV complications, particularly ureteral strictures, most of which occurred prior to June 2021. We suggest that urologists should appreciate the risks associated with the use of novel technologies and be thoughtful about technology uptake.