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

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.

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.

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.

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.