To characterize and compare adverse events (AEs) associated with thulium fiber lasers (TFL) and holmium: YAG lasers (Ho: YAG) in urology, particularly assessing changes in TFL-related AEs following the 2021 FDA recall, which is crucial for understanding safety implications.
Key Findings:
Out of 1629 events analyzed, 467 were TFL-related and 487 were Ho: YAG-related after exclusions.
Interpretation:
The study indicates that while both laser types are generally safe, Ho: YAG lasers have a higher incidence of patient-related adverse events, whereas TFLs exhibit more device-related issues. The FDA recall appears to have positively impacted the safety profile of TFLs, suggesting a need for ongoing monitoring.
Limitations:
The study is based on reported data, which may not capture all adverse events, and potential biases in reporting could affect the findings.
Focus on specific procedures may limit the generalizability of findings.
Conclusion:
This analysis highlights the importance of ongoing surveillance of laser devices in urology and suggests that the TFL may offer a safer profile post-recall compared to Ho: YAG lasers, warranting further research.
