title: Postmarketing Analysis of a Novel, Cordless Ultrasonic Dissector.
abstract: Introduction Tissue dissection and vessel sealing is performed using a variety of energy sources and surgical devices. We describe the postmarketing analysis of a cordless ultrasonic dissector and vessel sealer in a series of general and gynecological procedures. Methods Patients were prospectively screened and consented for participation. Data collected included demographics, device activations/seals and failures, and patient complications. Surgeons were surveyed following each case. Data was analyzed using standard statistical methods. Results A total of 110 patients were consented and participated in the study. The most frequently performed procedures were bilateral salpingo-oophorectomy (n = 48) and total laparoscopic hysterectomy (n = 36). Mean age was 54.2 years and 79.2% were female. The most frequent number of device activations per case was between 26 and 50 (36.6%). Five failed seals occurred out of 4858 total estimated seals (0.11%). Failed seals were felt to be due to thickened, scarred tissue not amenable to device compression. There were no patient intraoperative complications related to the device itself. 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 procedures. In this study, there were no complications related to the device itself. The remarkable cordless design of this device enhances its ease of use with overall excellent effectiveness.
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: Erin H
authors.initials: EH
authors.lastname: Baker
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: Russell C
authors.initials: RC
authors.lastname: Kirks
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: Jessica
authors.initials: J
authors.lastname: Drummond
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Naumann
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Stefanidis
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: Ryan Z
authors.initials: RZ
authors.lastname: Swan
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: John B
authors.initials: JB
authors.lastname: Martinie
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA.
authors.forename: Dionisios
authors.initials: D
authors.lastname: Vrochides
authors.affiliation: Carolinas Medical Center, Charlotte, NC, USA david.iannitti@carolinashealthcare.org.
authors.forename: David A
authors.initials: DA
authors.lastname: Iannitti
mesh_terms: D004210:Dissection / Q000295:instrumentation; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D013502:General Surgery / Q000295:instrumentation* / Q000379:methods; D013509:Gynecologic Surgical Procedures / Q000295:instrumentation* / Q000379:methods; D006801:Humans; D008297:Male; D019060:Minimally Invasive Surgical Procedures / Q000295:instrumentation / Q000379:methods; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D013525:Surgical Instruments; D014465:Ultrasonics / Q000295:instrumentation*
keywords: laparoscopic surgery; minimally invasive surgery; tissue dissection; ultrasonic dissector; vessel sealing