Design: Review of Manufacturer and User Facility Device Experience (MAUDE) database from 2013 to 2023

Setting: N/A

Patients or Participants: N/A

Interventions: We queried the MAUDE database, a voluntary reporting system published by the Food and Drug Administration (FDA) for MDRs. Each MDR was reviewed individually and categorized by type of complication, nature of event according to user and manufacturer, and reporter type.

Measurements and Main Results: From 2012 to April 2023, 122 MDRs related to RTs were identified, with 120 MDRs included for analysis (2 were misclassified). Reporting was most often from the manufacturer (90.1%). Discovery was most often intraoperatively during myomectomy (N=52). User reports most often cited “broken wires” (N=88) and “broken jaws” (N=19). Manufacturer failure analysis identified "broken pitch cable” in 95% (N=114) of reports, caused by component failure (87%) or mishandling/misuse (12%). During manufacturer inspection, 35% (N=42) noted a crimp missing. Per manufacturer notes, “if a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient”. Notably, only 4 reports explicitly identified a fragment falling into the patient.

Conclusion: Over 10 years, 120 RT MDRs were voluntarily reported to the FDA. Underestimation is possible as reporting rarely occurred by surgeons or facilities. Notably, 35% of defective RTs were reported to have a crimp missing on manufacturer inspection, which per manufacturer narrative could feasibly lead to a retained foreign body. This study demonstrates that although the number of reported MDRs for RTs is relatively small, these reports are consistent and have the potential to significantly impact patient care. Continued vigilance and improved RT device problem reporting from surgeons and facilities should be encouraged.