7723 Adverse Events Using Advanced Sealing Devices during Vaginal Hysterectomy: An Analysis of the Maude Database

Abstract

<h3>Study Objective</h3> To identify visceral injuries associated with the use of advanced sealing devices at the time of vaginal hysterectomy. <h3>Design</h3> Retrospective review. <h3>Setting</h3> Analysis of the Manufacturer and User Facility Device Experience (MAUDE) database for reported visceral injuries from 11/1/1990 – 11/1/2021. <h3>Patients or Participants</h3> MAUDE was queried for the Brand Name ‘LigaSure Impact' and ‘ENSEAL x1' and Event Type ‘Injury' associated with vaginal hysterectomy. Two individuals independently reviewed events identified. <h3>Interventions</h3> N/A. <h3>Measurements and Main Results</h3> A total of 102 events were recorded. Following removal of duplicate entries, there were a total of 92 reports of injury [LigaSure Impact n=50, ENSEAL x1 n=42]. Of these reports, 29 were during hysterectomy of all types [LigaSure Impact: 11/50 (22%), ENSEAL x1: 18/42 (43%)], of which 9 were during vaginal hysterectomy [LigaSure Impact: 4/11 (36%), ENSEAL x1: 5/18 (28%)] including 2 thermal skin injuries, 1 ureteral injury, 1 bladder injury and 5 unspecified injuries attributed to device malfunction. No bowel injuries were identified. <h3>Conclusion</h3> Thermal injury is a rare but important complication associated with use of advanced sealing devices during vaginal hysterectomy. Vaginal surgeons must be aware of this potential adverse outcome and remain vigilant in preventing it.