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

STUDY OBJECTIVE

To investigate, describe, and compare adverse event reports (AERs) and their patterns amongst commonly used operative hysteroscopy devices.

DESIGN

A secondary analysis of the Manufacturer and User Facility Device Experience (MAUDE) published by the Food and Drug Administration.

SETTING

N/A.

PATIENTS OR PARTICIPANTS

Women who underwent hysteroscopic surgery, with adverse events reported to MAUDE.

INTERVENTIONS

Search terms within the MAUDE database included "resectoscope," "hysteroscopic reciprocating morcellator," "MyoSure," and "TruClear." Reports were categorized by device type, patient complications, and required interventions. Statistical analysis utilized Fisher's exact tests.

MEASUREMENTS AND MAIN RESULTS

Between January 2014 and April 2024, 1872 AERs were identified for hysteroscopes: 664 for resectoscopes and 1208 for morcellation devices (MyoSure, N = 645 and TruClear, N = 563). While absolute complication rates are not able to calculated from MAUDE, there were significant differences in the reporting of patient complications: resectoscope devices had higher frequency of infection (p < .01) while morcellation devices had higher frequency reporting of hemorrhage (p < .001), uterine perforation (p < .001), and bowel perforation (p < .001). Morcellation device AERs more often reported operative intervention (1.1% vs 12.4%, p < .001). Subgroup analysis comparing AERs of morcellation devices showed the majority (73.2%) of TruClear AERs registered no patient impact or harm, while only 21.2% of MyoSure AERs reported no patient impact. MyoSure device AERs had higher frequency of hemorrhage (p < .001), infections (p < .001), uterine perforations (p < .001), and bowel perforations (p < .001). Additionally, MyoSure AERs reported more surgical intervention compared to TruClear AEs (19.5% vs 4.3%, p < .001).

CONCLUSION

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.