Adverse Events When Using Advanced Sealing Devices During Vaginal Hysterectomy: An Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database

Objective: This research identified visceral injuries associated with use of 2 advanced sealing devices (LigaSure Impact,tm Covidien, Medtronic, Minneapolis, MN; and ENSEAL® x1 Tissue Sealer,™ Ethicon Endo-Surgery, Cincinnati, OH) during vaginal hysterectomies. Materials and Methods: This retrospective review was an analysis of the Manufacturer and User Facility Device Experience (MAUDE) database for reported visceral injuries from November 1,1990 to November 1, 2021. MAUDE was queried for the Brand Names LigaSure Impact and ENSEAL® x1 and for Event Type Injury associated with vaginal hysterectomy. Two individuals independently reviewed events that were identified. Results: A total of 102 events were recorded. Following removal of duplicate entries, there were 92 reports of injuries (LigaSure Impact [n = 50] and ENSEAL x1 [n = 42]). Of these reports, 29 were during hysterectomies of all types (LigaSure Impact: 11/50 [22%] and ENSEAL x1: 18/42 (43%]), of which 9 were during vaginal hysterectomies (LigaSure Impact: 4/11 [36%] and ENSEAL x1 (: 5/18 (28%]). There were 2 reports of thermal skin injuries during vaginal hysterectomies (ENSEAL x1 (n = 2]). No bowel injuries were identified. The other 7 injuries associated with vaginal hysterectomies were ureteral injuries, bladder injuries and unspecified injuries from device malfunctions. Conclusions: Visceral injuries are a rare but important complication associated with using advanced sealing devices during vaginal hysterectomy.