Abstract
Background
Description of energy-based genitourinary non-surgical devices (energy-based devices) safety data is outlined given their rapid adoption.
Objectives
To describe adverse events (AEs) for energy-based devices in the Manufacturer and User Facility Device Experience (MAUDE) database, and to compare to similar devices and other subspecialty applications. We hypothesized that products with genitourinary applications had similar AEs to dermatologic or general surgery applications.
Methods
Reed Tech™ Navigator compiled AE reports for all registered energy-based devices. Individual AE reports associated with 1) non-ablative, 2) fractionated, 3) unfractionated 4) radiofrequency, and 5) hybrid laser technologies were categorized. AE characteristics were compared among genitourinary applications (n=39) and other subspecialty applications within the same devices (n=79).
Results
Eighteen manufacturers were identified, which collectively manufacture 43 products with genitourinary applications. Thirty-nine genitourinary AEs were reported and isolated to 6 manufacturers with 11 products, of which 82% (n=32) were injuries, 15% (n=6) were device malfunction, and 3% (n=1) related to improper maintenance. Local treatment reactions were the most commonly reported injury (62%, n=21). AEs varied by device type with CO2 lasers having more burns and radiofrequency devices having higher rates of sensation loss. When comparing similar technology types, genitourinary energy-based devices had the least AE reports per device in MAUDE database.
Conclusions
AEs were reported on a quarter of the products currently available, and most were local treatment reactions. The reporting of AEs is equal to that of other subspecialties suggesting similar risk profiles. Improved reporting is needed to fully evaluate the safety of individual energy-based devices.
