2026 Proffered Presentations
S297: ADVERSE EVENTS ASSOCIATED WITH THE AQUAMANTYS BIPOLAR SEALER IN ENDOSCOPIC SURGERY
Sarah Yang, BS; Sabrina Nusraty, BS; Jane Tong, MD; Mohammed Labib, MD; Andrea Hebert, MD; University of Maryland School of Medicine
Objective: Endoscopic endonasal surgery has emerged as an effective, minimally invasive surgical approach that has transformed the field of skull base surgery. An often-encountered challenge is visualization of the surgical field, commonly caused by intraoperative bleeding masking the endoscopic lens. To mitigate visualization challenges during surgery, instruments designed to provide hemostatic control are becoming more refined. The Aquamantys bipolar sealer combines radiofrequency (RF) energy and continuous saline flow to provide hemostasis to exposed tissue or bone surfaces. This system offers many advantages but also presents risks to patients and operators, which have not been reported comprehensively. This study aims to summarize device malfunctions, patient complications, and subsequent interventions related to Aquamantys use.
Methods: The US Food and Drug Administration’s Manufacturer and User Facility Device Experience database was searched for reports of adverse events associated with Aquamantys use from December 2014 to November 2023. Data was extracted from most reports, excluding reports from obviously non-skull base surgery.
Results: One hundred and one reports involving Aquamantys use were identified, from which 108 events were extracted. Of these, 19 (17.6%) were adverse events to patients, 2 (1.9) were adverse events to operators, and 87 (80.5%) device malfunctions. Burns (10 [56.2%]) and post-operative wound healing complications (8 [42.1%]) were the most common adverse events to patients. One burn incident and one shock incident comprised the two total adverse events to operators. Electrical/generator issue (26 [29.9%]) and contaminated packaging (17 [19.5%]) were the most common device malfunctions.
Discussion: The Aquamantys bipolar sealer has demonstrated utility in endoscopic endonasal surgery, but not without risks. This study discusses adverse events and device malfunctions pertaining to this device and emphasizes shortcomings in current reporting.
Implications for Practice: A standardized system of reporting with clear a priori categorization is needed to better understand adverse events related to Aquamantys use and to allow accurate determination of the causes associated with device malfunctions.