da Vinci Surgery
 

Important Patient Safety Information

Surgical Risk

All surgery presents risks, including da Vinci® Surgery.

Serious complications may occur with da Vinci Surgery, up to and including death. Examples of serious and life-threatening complications, which may require hospitalization, include:

  • Injury to tissues or organs
  • Bleeding
  • Infection
  • Internal scarring that can cause long-lasting dysfunction or pain

Temporary pain or nerve injury has been linked to the inverted position often used during abdominal and pelvic surgery.

Patients should consider that risks of any surgery include:

  • Potential for human error
  • Potential for equipment failure

Risks specific to minimally invasive surgery may include:

  • A longer operative time
  • The need to convert the procedure to an open approach
  • The need for additional or larger incision sites
  • Converting the procedure could mean a longer operative time, a long time under anesthesia, and could lead to increased complications
  • For patients undergoing a hysterectomy for presumed benign reasons who have an undiagnosed cancer, there may be a risk of cancer cells spreading to the abdomen if the uterus is cut into pieces for removal.

Results, including cosmetic results, may vary.

Medical Advice & Surgeon Training

Patients should talk to their doctors to decide if da Vinci Surgeryis right for them. Other surgical approaches are available. Only a doctor can determine whether da Vinci Surgery is appropriate for a particular patient's situation.

Only surgeons who have developed adequate robotic skills to perform the tasks associated with each procedure and who have received specific training in the use of the da Vinci Surgical System should use the system. Training provided by Intuitive Surgical is limited to the use of its products and does not replace the necessary medical training and experience required to perform surgery. Patients should ask their surgeon about his/her experience using the da Vinci System and about the surgeon's results. As with any surgery, results may improve with increased experience.

da Vinci Surgical System Description

The da Vinci Surgical System is designed to help surgeons perform minimally invasive surgery. The da Vinci Surgical System is not able to act on its own. Instead, the surgery is performed entirely by a doctor, who controls the system. The da Vinci System offers surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. It uses specialized instrumentation, including: a miniaturized surgical camera, wristed scissors, scalpels and forceps – all designed to help with delicate dissection and reconstruction deep inside the body.

Risks Specific to the da Vinci Surgical System

The same risks associated with other forms of surgery also apply to da Vinci Surgery.

When is the da Vinci Surgical System Used?

The da Vinci System is used for specific minimally invasive, robotic-assisted procedures in the following specialty areas:

  • Urologic surgery
  • General surgery performed through the abdominal wall
  • Gynecologic surgery
  • Head & neck surgery performed through the mouth restricted to benign (non-cancer) and malignant tumors (cancer) classified as T1 and T2 (early stage cancer)
  • Thoracic surgery performed through the rib cage on structures like the lungs
  • Heart surgery performed through the rib cage

da Vinci Surgery with Single-Site® Instruments is cleared for use in gallbladder removal, and for hysterectomy and ovary removal for benign conditions.

The da Vinci Surgical System is used on adults in the specialty areas described above. It is also used on children, except for conditions affecting the head and neck. It is intended only for use by trained medical professionals in an operating room environment and according to the manufacturer's product documentation. Specific representative procedures are included in the Professional Instructions for Use.

When the da Vinci Surgical System is Not Used

A surgeon may decide not to use the da Vinci System for the same reasons he or she decides not to use traditional minimally invasive surgery. Patients who bleed easily, have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci Surgery.

More Information about the da Vinci Surgical System

If you have questions about the da Vinci Surgical System or da Vinci Surgery procedures, consult with a qualified surgeon. Surgeons experienced with the da Vinci Surgical System can be found using the Surgeon Locator. Intuitive Surgical provides surgeons training on the use of the da Vinci System but does not certify or qualify the surgeons listed in the Surgeon Locator tab.

When are Single-Site® Instruments Used and What are the Risks?

da Vinci Surgery with Single-Site Instruments is cleared for use in gallbladder removal, and for hysterectomy and ovary removal for benign conditions. Patients who bleed easily, have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci Surgery with Single-Site Instruments. Research suggests that there may be an increased risk of incision-site hernia with single-incision surgery.

da Vinci Surgery with Single-Site Instruments and accessories is cleared for use in gallbladder removal, and for hysterectomy and ovary removal for benign conditions. Patients who bleed easily, have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci Surgery with Single-Site Instruments. The safety and effectiveness of Single-Site instruments for use in the performance of general laparoscopic abdominal surgery procedures have not been established.

PN 1002361 Rev A 04/2013

All surgery presents risk, including da Vinci® Surgery and other minimally invasive procedures.  Serious complications may occur in any surgery, up to and including death. Examples of serious or life-threatening complications which may require hospitalization include injury to tissues or organs, bleeding, infection or internal scarring that can cause long-lasting dysfunction or pain. Temporary pain or nerve injury has been linked to the inverted position often used during abdominal and pelvic surgery. Risks of surgery also include potential for equipment failure and human error. Risks specific to minimally invasive surgery may include: A long operation and time under anesthesia, conversion to another technique or the need for additional or larger incisions.  If your surgeon needs to convert the procedure, it could mean a long operative time with additional time under anesthesia and increased complications. Temporary pain or discomfort may result from pneumoperitoneum, the presence of air or gas in the abdominal cavity used by surgeons in minimally invasive surgery. Research suggests that there could be an increased risk of incision-site hernia with single-incision surgery. Results, including cosmetic results, may vary.  Patients who bleed easily, who have abnormal blood clotting, are pregnant or morbidly obese are typically not candidates for minimally invasive surgery, including da Vinci® Surgery. For more complete information on surgical risks, safety, and indications for use, please refer to http://www.davincisurgery.com/safety/. Patients should talk to their doctors about their surgical experience and to decide if da Vinci Surgery is right for them. Other options may be available. Intuitive Surgical reviews clinical literature from the highest level of evidence available to provide benefit and risk information about use of the da Vinci Surgical System in specific representative procedures. We encourage patients and physicians to review all available information on surgical options and treatment in order to make an informed decision. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed.

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