Comparative Analysis of Thulium Fiber and Holmium: YAG Lasers in Urology: Findings from the FDA MAUDE Database
By
Juanita Velasquez Ospina
Etienne Gozlan
Adam Williams
Aravindh Rathinam
Archan Khandekar
Jonathan Katz
Robert Marcovich
Hemendra N. Shah
October 4, 2025
Clinical Scorecard: Comparative Analysis of Thulium Fiber and Holmium: YAG Lasers in Urology: Findings from the FDA MAUDE Database
At a Glance
Category Detail
Condition Urologic procedures involving laser use, including lithotripsy and prostate interventions Key Mechanisms Ho: YAG laser (2120 nm wavelength) and TFL (1940 nm wavelength) operate via water absorption for stone ablation and tissue treatment Target Population Patients undergoing urologic procedures requiring laser technology Care Setting Surgical and procedural settings in urology
Key Highlights
TFL shows higher fiber break rates but fewer patient adverse events compared to Ho: YAG lasers. Ho: YAG lasers have more device malfunctions and patient events, with mostly minor (Gupta Level I) adverse events. FDA recall of TFL devices in 2021 led to significant reduction in patient harm and fiber breakages. Guideline-Based Recommendations
Diagnosis
Utilize MAUDE database surveillance to identify device-related adverse events in urologic laser procedures. Management
Apply FDA safety updates and software modifications post-recall to reduce thermal injury risks with TFL devices. Consider pulse modulation settings (e.g., MOSES) to balance fiber break rates and procedure cancellations in Ho: YAG lasers. Monitoring & Follow-up
Ongoing post-market surveillance of laser devices for device malfunctions and patient adverse events. Monitor severity of adverse events using Gupta classification to guide clinical response. Risks
Device malfunctions including console errors, overheating, and fiber breaks. Patient risks including minor to severe adverse events such as thermal injury and, rarely, fatal complications. Procedure cancellations more frequent with certain pulse modulation settings. Patient & Prescribing Data
Patients undergoing urologic laser procedures including lithotripsy and prostate treatments
TFL devices post-FDA recall demonstrate improved safety profiles with fewer patient harms; Ho: YAG lasers remain effective but have higher device malfunction rates.
Clinical Best Practices
Adhere to manufacturer power presets and updated safety protocols, especially for TFL devices. Employ pulse modulation techniques judiciously to minimize fiber breakage and procedure cancellations. Classify and grade adverse events using standardized systems (e.g., Gupta classification) for consistent reporting and management. Incorporate MAUDE database findings into clinical decision-making to enhance patient safety. References
