Thulium fiber vs. holmium: YAG lasers in urology: insights from the FDA MAUDE database.

Abstract

Purpose: To compare adverse events (AEs) associated with Thulium Fiber Lasers (TFLs) and Holmium: YAG (Ho: YAG) lasers reported in the FDA MAUDE database, and to examine changes in TFL-related AEs following the FDA's 2021 Class II recall.

Methods: The FDA MAUDE database was searched for events between 2018 and 2024 using "LUMENIS MOSES," "LUMENIS VERSAPULSE," "SOLTIVE," and "TFL + {YEAR}." Events were classified as device, patient, staff or environmental, and graded using the Gupta system (Levels I-IV). Exclusions included non-urologic procedures, insufficient detail, or duplicates. Subgroup analyses considered prostate vs. non-prostate, TFL pre- vs. post-recall, and Ho: YAG by pulse modulation (MOSES vs. standard). Chi-square or Fisher's exact tests were used for categorical data, and Wilcoxon rank-sum tests for Gupta comparisons.

Results: 954 events were included (467 TFL, 487 Ho: YAG). Console malfunctions were more common with Ho: YAG (44.4%, p < 0.0001), while fiber breaks more with TFLs (57%, p < 0.0001). Patient-involving AEs occurred more with Ho: YAG (35.3%) compared to TFLs (13.5%, p < 0.0001). Most events were Level I: 83.9% TFL vs. 59.3% Ho: YAG (p < 0.0001). Level II events were higher with Ho: YAG (39.8%), and Level III with TFLs (2.1%, p = 0.0436); one Level IV event occurred (Ho: YAG group). Post FDA recall, TFL-related Level II and III events decreased significantly. Prostate vs. non-prostate stratification showed no differences. MOSES use in Ho: YAG had fewer fiber issues, but more Level II events compared to standard holmium.

Conclusion: Lasers in urology appear safe, with most AEs being free of patient or staff harm and classified as minor. Post-recall improvements in TFL safety profiles suggest effective corrective action.