Surgical Specialties

Regulatory Clearance

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 (except for transoral otolaryngology surgical procedures).

The da Vinci Surgical System is intended for us 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

  • Hysterectomy, myomectomy and sacrocolpopexy

  • Cholecystectomy, Nissen fundoplication, Heller myotomy, gastric bypass, donor nephrectomy,adrenalectomy, splenectomy and bowel resection

  • 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

  • Oropharyngeal, laryngeal and hypopharyngeal resections; floor of mouth and oral cavity resections


While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications. Before you decide on surgery, discuss treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your individual situation. Surgery with the da Vinci Surgical System may not be appropriate for every individual; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as their risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for your situation. The clinical information and opinions, including any inaccuracies expressed in this material by patients or doctor about da Vinci Surgery are not necessarily those of Intuitive Surgical, Inc. and should not be considered as substitute for medical advice provided by your doctor. All persons depicted are models unless otherwise noted. © 2012 Intuitive Surgical. All rights reserved. Intuitive, Intuitive Surgical, da Vinci, da Vinci S, da Vinci Si, Single-Site,  InSite, TilePro and EndoWrist are trademarks or registered trademarks of Intuitive Surgical. All other product names are trademarks or registered trademarks of their respective holders.








 

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