The U.S. Food and Drug Administration (FDA) has cleared the da Vinci® Surgical System for use in urological surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures.
The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (with the exception of transoral otolaryngology surgical procedures in pediatric patients).
The da Vinci Surgical System is intended for use by trained physicians in an operating room environment in accordance with representative, specific procedures set forth in the Professional Instructions for Use.
Representative Uses: The da Vinci System has been successfully used in the following procedures, among others:
- Radical prostatectomy, pyeloplasty, cystectomy, nephrectomy, ureteral reimplantation
- Cholecystectomy, Nissen fundoplication, Heller myotomy, gastric bypass, donor nephrectomy, adrenalectomy, splenectomy, bowel resection and other colorectal procedures
- Oropharyngeal, laryngeal and hypopharyngeal resections; floor of mouth and oral cavity resections
- Hysterectomy, myomectomy and sacrocolpopexy
- Internal mammary artery mobilization and cardiac tissue ablation
- Mitral valve repair, endoscopic atrial septal defect closure
- Mammary to left anterior descending coronary artery anastomosis for cardiac revascularization with adjunctive mediastinotomy
PN 874174 Rev A 08/11