Food and Drug Administration Database Secondary Analysis: Difference in Operative Hysteroscopy Device Adverse Event Reporting

While conclusions within the MAUDE database are limited, especially given the lack of data concerning the volume of surgeries done with each device and the voluntary reporting mechanism, there are significant differences in the types of adverse events reported among operative hysteroscopy instruments. Morcellation AERs had a significantly higher frequency of patient complications and described more surgical interventions compared to AERs for resectoscopes. When comparing MyoSure and TruClear, MyoSure AERs described a significantly greater proportion of serious patient complications compared to TruClear device AERs. Devices with similar functions may differ in how stakeholders report complications.