The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.
Patients between the ages of 18 and 80 years of age
Either male or female
BMI ≤ 26 kg/m2
ASA ≤ 3
Subject requiring an emergent operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Single group
da Vinci SP® Single-Port Robotic Surgical System
DeviceThe da Vinci SP® Surgical System is designed to enable the performance of surgical procedures using a minimally invasive single-port approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.
Completion Using the planned da Vinci SP-assisted Single Port Robot.
The number of subjects who completed the planned da Vinci SP-assisted operation without conversion to an alternate approach. Conversion to an alternate approach comprises conversion to open, multiport laparoscopic, multiport robotic or hand-assisted approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned operation using the alternate approach.
Intraoperative and post-operative adverse events
The incidence of all intraoperative and post-operative adverse events that occur through the 24-month follow-up period.
Number of Positive resection Margins
Number of positive resection margins in patients with Malignant disease.
Number of Lymph node yield
Number of lymph node yield in patients with Malignant disease.
Physical Status Classification
Assessment of the fitness of patient before surgery using the ASA Physical Status Score: Class I - A patient in normal health Class II - A patient with mild systemic disease resulting in no functional limitations Class III - A patient with severe systemic disease that limits activity, but is not incapacitating Class IV - A patient with severe systemic disease that is a constant threat to life Class V - A moribund patient not likely to survive without the operation Class VI - A patient already declared brain dead whose organs are being removed for donor purposes
Charlson Comorbidity Index Score
Predicts one-year mortality for patients with a range of comorbid conditions, helping the physician determine how aggressively to treat a condition. This index score is assessed by assigning points (1,2,3 or 6) based on the likelihood of dying associated to 17 different conditions (co-morbidities). Scores are summed to provide a total score to predict mortality. Comorbidity classification is categorized as low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7), and very high comorbidity (score ≥ 8)
Operative Time
Measured in minutes
Estimated blood loss
Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery.
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