DOI: 10.11648/j.js.20221005.15 ISSN: 2330-0930

Safety and Performance of the HD1000i Shears in Urologic Procedures: A Retrospective Review

Mordechai Goode Sadowsky, Won Sik Jang, Subin Lim, DongKyu Kim, Jason Robert Waggoner, Philippe Grange, Paula Priscilla Veldhuis, Giovanni Antonio Tommaselli
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Background: Ultrasonic devices including the Harmonic HD1000i Shears are utilized for incision, dissection, and separation and division of tissues to achieve hemostatic transection of vessels in a wide range of procedures. This study was conducted to further evaluate the safety and performance of the HD1000i in a clinical setting use during urologic procedures. Methods : The primary endpoint of this retrospective, observational, single-arm study was intra- and post-operative transfusions deemed related to study device. Secondary endpoints were occurrences of intra-operative and post-operative adverse events (AEs) or complications possibly related to the procedure or device. Adult patients who underwent open cystectomy (OC), or laparoscopic (LN) or open nephrectomy (ON) from May 1, 2018 to November 30, 2020 at Severance Hospital (South Korea) where the device had been utilized (without the use of alternative advanced energy device used) were included in this study. Results : One-hundred and five subjects met inclusion criteria: 48 in OC, 18 in ON, and 39 in LN. Overall blood transfusion rates were 52.1% (25/48), 38.9% (7/18), and 5.1% (2/39) for the OC, ON, an LN groups, respectively, and 32.4% (34/105) overall. AE’s/complications were reported in 2.9% of subjects: one in the ON group (6%) and 2 in the LN subset (5%). Conclusion : Analysis of a single institution’s experience with the Harmonic HD1000i device in urologic surgery demonstrates acceptable safety and efficacy comparable to the published literature.

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