MP29-14: Single-use and Reusable Ureteroscope Related Malfunctions and Adverse Events: An Analysis of the Manufacturer and User Facility Device Experience Database
Saturday, May 4, 2024 9:30 AM to 11:30 AM · 2 hr. (US/Central)
302B
Abstract
Information
Full Abstract and Figures
Author Block
Brenna S Kincaid*, Augusta, GA, Ryan Hsi, Nashville, TN
Introduction
Single-use ureteroscopes were developed to address the limitations of reusable ureteroscopes. The aim of this study was to investigate a manufacturer based reporting database to compare types of malfunctions and patient outcomes comparing single-use versus reusable ureteroscopes.
Methods
We identified injury, malfunction, or death event reports for ureteroscopes in the Manufacturer and User Facility Device Experience (MAUDE) database dated from September 2022 to August 2023. After exclusion of misclassified or duplicate reports (n=64), there were 352 event reports included. We identified the ureteroscopes as single-use or reusable and classified injury events by severity and relationship of device to event using the MAUDE classification system. Types of malfunctions and patient outcomes were compared between single-use and reusable ureteroscopes.
Results
Of 352 reports, 32 (9%) were for single-use and 320 (91%) were for reusable ureteroscopes. The most common malfunctions for single-use and reusable ureteroscopes were “no display” (26%) and “break” (19%), respectively (see Table). Overall, the most common post-operative problems were “foreign body in patient” (12%) and “urinary tract infection” (UTI) (12%), of which all cases (n=7) were for single-use ureteroscopes and deemed possibly related to the device. Of the definitely or possibly related events, severity of complications for single-use ureteroscopes were mild, moderate or severe in 28%, 44% and 17% of cases, respectively. Severity of complications for reusable ureteroscopes were mild, moderate, or severe in 7%, 40%, and 47% of cases, respectively. There were proportionally more injury reports for single-use versus reusable ureteroscopes (58% vs. 6%, p=value <0.001).
Conclusions
Single-use and reusable ureteroscopes have distinct patterns of equipment failure with some events contributing to adverse patient outcomes. These data suggest that users should be prepared for the potential for intra-operative malfunction to minimize patient harm.
Source Of Funding
No funding source.
Author Block
Brenna S Kincaid*, Augusta, GA, Ryan Hsi, Nashville, TN
Introduction
Single-use ureteroscopes were developed to address the limitations of reusable ureteroscopes. The aim of this study was to investigate a manufacturer based reporting database to compare types of malfunctions and patient outcomes comparing single-use versus reusable ureteroscopes.
Methods
We identified injury, malfunction, or death event reports for ureteroscopes in the Manufacturer and User Facility Device Experience (MAUDE) database dated from September 2022 to August 2023. After exclusion of misclassified or duplicate reports (n=64), there were 352 event reports included. We identified the ureteroscopes as single-use or reusable and classified injury events by severity and relationship of device to event using the MAUDE classification system. Types of malfunctions and patient outcomes were compared between single-use and reusable ureteroscopes.
Results
Of 352 reports, 32 (9%) were for single-use and 320 (91%) were for reusable ureteroscopes. The most common malfunctions for single-use and reusable ureteroscopes were “no display” (26%) and “break” (19%), respectively (see Table). Overall, the most common post-operative problems were “foreign body in patient” (12%) and “urinary tract infection” (UTI) (12%), of which all cases (n=7) were for single-use ureteroscopes and deemed possibly related to the device. Of the definitely or possibly related events, severity of complications for single-use ureteroscopes were mild, moderate or severe in 28%, 44% and 17% of cases, respectively. Severity of complications for reusable ureteroscopes were mild, moderate, or severe in 7%, 40%, and 47% of cases, respectively. There were proportionally more injury reports for single-use versus reusable ureteroscopes (58% vs. 6%, p=value <0.001).
Conclusions
Single-use and reusable ureteroscopes have distinct patterns of equipment failure with some events contributing to adverse patient outcomes. These data suggest that users should be prepared for the potential for intra-operative malfunction to minimize patient harm.
Source Of Funding
No funding source.