Post Marketing Anaylsis of a Novel, Cordless Ultrasonic Dissector

Erin H Baker, MD, Jessica M Drummond, RN, Ramanathan M Seshadri, MD, Wendel Naumann, MD, Dimitrios Stefanidis, MD, Iain H McKillop, PhD, Ryan Z Swan, MD, John B Martinie, MD, David A Iannitti, MD. Carolinas Medical Center

Introduction: Tissue dissection and vessel sealing in the operating room can be performed using a variety of energy sources and surgical devices. Sonicision™ is a cordless ultrasonic dissector and vessel sealer for use in laparoscopic and open surgery. We describe the post marketing analysis of this novel device in a variety of general and gynecological procedures.

Methods: Patients undergoing laparoscopic and open general surgical and gynecologic procedures were prospectively screened and consented for participation in the study. Data collected included patient demographics, device activations including number of seals, device failures, seal failures, patient complications and follow up. Surgeons were surveyed following each case regarding ease of use, intraoperative visualization, and device failures using a Likert scale. Data was analyzed using standard statistical methods, appropriate to the variable type. Descriptive statistics used to describe the study population included means, standard deviation, counts, and percentages.

Results: Eighty two patients were consented and participated in the study. The most frequently performed procedures were bilateral salpingo-oophorectomy (28), total laparoscopic hysterectomy (24), and cholecystectomy (13). Combined procedures were frequently performed including pancreatecomy, splenectomy, small bowel resection, and cystgastrostomy. Mean age was 54.2 years and there were 65 (79.2 %) females. The most frequent number of device activations per case was between 26-50 (36.6%). There was one device failure related to a battery housing component. Battery change during the procedure occurred in 5 cases, of which 3 were felt to be due to incomplete charge in sterile processing prior to the procedure. On average, battery change was required after 90.6 (16-220) device activations. However, in cases in which a fully charged battery was used, battery change was required after 185 device activations. There were 4 failed seals out of 3,594 total estimated seals (0.11%). Failed seals were felt to be due to thickened, scarred tissue not amenable to device jaw compression. Failed vessel sealing required use of an alternative device for hemostasis in 3 cases. There were no patient intraoperative or postoperative complications felt to be related to the device. Overall, surgeons felt the device was extremely easy to use (97.6%) and no visual obstruction due to steam from the device was encountered (95%). Ninety five percent of surgeons felt the device was beneficial for soft tissue dissection and vessel sealing.

Conclusion: Sonicision™ is safe and effective for use in dissection of soft tissues and vessel sealing in a variety of laparoscopic and open general gastrointestinal and gynecologic procedures. In this study, there were no complications related to the device itself. The remarkable cordless design of this device significantly enhances its ease of use with overall excellent effectiveness.

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