Foregut^* Surgery with Da Vinci 5: Designed for Enhanced Precision and Operational Efficiency

*Heller Myotomy, Hiatal/Paraesophageal/Sliding Hernia Repair, Dor Fundoplication, Toupet Fundoplication, Nissen Fundoplication.

Financial disclosure

The physicians have received compensation from Intuitive for consulting and/or educational services.

HCP opinion disclosure

Intuitive is sponsoring this presentation. The surgeons are presenting at the request of Intuitive and have received compensation from Intuitive for consulting and/or educational services. The views and opinions expressed are the surgeons alone and do not necessarily reflect the official policy or position of Intuitive. The information being presented is consistent with U.S. Food and Drug Administration guidelines, and other regulatory agencies around the world, and is not intended to promote the off-label use of the discussed product(s). All content is created and published for informational purposes only. It is not meant to offer medical, legal, accounting, regulatory compliance, or reimbursement advice and is not intended to establish a standard of care. Please consult professionals in these areas if you have related questions or concerns.

Indications for use / intended use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci 5 Surgical System) shall assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures and general thoracoscopic surgical procedures. The system is indicated for adult use.

It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

Contraindication

Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

Precaution for representative uses

The demonstration of safety and effectiveness for the representative-specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease or condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

For risks, cautions, and warnings and full prescribing information, refer to the associated user manual(s).

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