One Decade Since the Advent of the Single-Use Flexible Ureteroscope: What Can We Learn from Device Malfunction Reporting Patterns?
Kyra Gassmann, Juan Serna, Ziv Savin, Veda Malhotra, Shrinkhala Kaphle, William Atallah, Mantu GuptaIntroduction and Objectives:
The availability and variety of single-use flexible ureteroscopes has drastically increased in the United States over the past decade. Our objective was to identify how trends in flexible ureteroscope device malfunctions have changed with this new technology.
Methods:
The manufacturer and user facility device experience database was queried with the keyword “flexible ureteroscope” to identify reports from 2015 to August 2025. Duplicates and reports unrelated to primary ureteroscope malfunctions were excluded. The reports were grouped into single-use or reusable scopes, classified into seven malfunction categories, and assigned a Gupta severity classification.
Results:
A total of 976 reports were identified. Three hundred two reports remained after applying exclusion criterion. Single-use scope malfunctions outnumbered reusable scopes reports since 2018. There were 10 (4.9%) severe/life-threatening events for single-use scopes, and 20 (20.2%) for reusable. One hundred ninety-three (95.1%) mild-moderate adverse events were reported for single-use scopes, and 79 (79.8%) for reusable scopes. For single-use scopes, electronic hardware malfunctions rendering scopes unusable peaked in 2020 at 72.2% but decreased to 7.1% in 2025. Packaging sterility issues initially increased to 40.0% in 2017, trended under 10% from 2018 to 2023, and experienced an uptick in 2024 to 42.4%. Image display issues were the most consistent problem averaging at 16.9% over the 10-year period. Difficulty removing scopes and working channel issues were rare, averaging 3.7% and 3.4% over 10 years, respectively.
Conclusions:
The increase of single-use scope malfunction reports since 2018 compared with reusable scope may indicate the widespread adoption of the technology. The frequency of severe or life-threatening events remained much lower than reusable scopes, which may support an adequate safety profile for single-use scopes. Lastly, there has been a substantial decrease in the electronic hardware malfunction reports over the past decade, which may indicate an increase in the quality of single-use scopes.