Intuitive da Vinci
World class1 robotic surgical systems
Design and implementation have been rigorously evaluated and awarded third-party certifications for privacy and security compliance with globally recognized HITRUST and NIST Cybersecurity & Privacy Frameworks.
Important safety information
Serious complications may occur in any surgery, including surgery with a da Vinci system, up to and including death. Examples of serious or life-threatening complications, which may require prolonged and/or unexpected hospitalization and/or reoperation, include but are not limited to, one or more of the following: injury to tissues/organs, bleeding, infection, and internal scarring that can cause long-lasting dysfunction/pain.
Risks specific to minimally invasive surgery, including surgery with a da Vinci system, include but are not limited to, one or more of the following: temporary pain/nerve injury associated with positioning; a longer operative time, the need to convert to an open approach, or the need for additional or larger incision sites. Converting the procedure could result in a longer operative time, a longer time under anesthesia, and could lead to increased complications. Contraindications applicable to the use of conventional endoscopic instruments also apply to the use of all da Vinci instruments.
For important safety information, including surgical risks and considerations, please also refer to www.intuitive.com/safety. For a product’s intended use and/or indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).
Individual outcomes may depend on a number of factors—including but not limited to—patient characteristics, disease characteristics, and/or surgeon experience.
Da Vinci 5 Indications for Use/Intended Use
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) 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).
Da Vinci Xi/X system
The demonstration of safety and effectiveness for the representative specific procedures 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/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.
Da Vinci SP system (TORS and URO)
The safety and effectiveness of this device for use in the performance of general laparoscopic surgery procedures have not been established. This device is only intended to be used for single port urological procedures and for transoral otolaryngology surgical procedures in the oropharynx for benign tumors and malignant tumors classified as T1 and T2 with the da Vinci EndoWrist SP Instruments and the da Vinci SP surgical system (SP1098).
Da Vinci instruments & accessories
It is the responsibility of the owner of the da Vinci surgical system to properly train and supervise its personnel to ensure that the instruments and accessories are properly cleaned, disinfected, and sterilized as required by the user’s manual. Da Vinci products should not be used in a clinical setting unless the institution has verified that these products are properly processed in accordance with the da Vinci system user manual.
