(1001) A MAUDE Database Analysis of Bipolar Energy Devices for Tonsillectomy

Introduction: Since Food and Drug Administration approval in 2018, bipolar cautery tonsillectomy devices have been increasingly utilized in the pediatric population for tonsillectomies. While such devices have generally been considered as safe and effective, their possible adverse events have not yet been elucidated. This study examined the Manufacturer and User Facility Device Experience (MAUDE) database to characterize these adverse events.

Methods: The MAUDE database was reviewed for all reports related to adverse events involving bipolar devices used for tonsillectomy from 2017 to 2023. Reports were individually reviewed and stratified into device-related and patient-related events. The prevalence of the most commonly reported adverse events, as well as measures of association of device malfunction and patient-related outcome, were calculated.

Results: A total of 83 adverse events were analyzed. Of the reports, 72.3% (n = 60) were patient-related, while the remaining 27.7% (n = 23) were solely device-related. Reports of device malfunction included device-jaw malfunction (19.3%, n = 16), inappropriate seal (14.5%, n = 12), and inappropriate energy output (39.8%, n = 33). The most common patient-related outcomes included postoperative bleeding (59%, n = 49), readmission (51.8%, n = 43), and reoperation (34.9%, n = 29). Average time to postoperative bleeding was 6.3 days with 30.6% of events occurring within 3 days of operation, 22.4% within 4-7 days, and 25% after 8 or more days. Inappropriate energy output was associated with postoperative bleeding within 3 days of tonsillectomy [OR: 3.38; 95% CI:(1.02,11.21)].

Conclusions: The most commonly reported adverse events associated with the devices included jaw and seal malfunction, as well as postoperative bleeding, readmission, and reoperation. Inappropriate energy output was associated with risk of early postoperative bleeding.