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DA VINCI® SINGLE-SITE™ HYSTERECTOMY Advancing Minimally Invasive Care for Women

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Unstable, 2D Optics1,2,3

Challenging Ergonomics & Instrument Crowding1,2,4

Lack of Triangulation1,2,4

THE CHALLENGE

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6 Week Post-Op Single-Site Incision

SURGICAL PRECISION SINGLE INCISION + THE OPPORTUNITY

STABLE 3DHD VISION

RESTORED TRIANGULATION

PRECISE ERGONOMIC CONTROL

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THE COMPARISON

dV Single-Site8 Lap Single Port7 vs

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• Existing Si system & 8.5 mm scope

• New cannulas

• Semi-rigid instruments

• 5-lumen port

˗ 2x da Vinci instruments

˗ Scope

˗ Assist cannula

˗ Insufflation

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THE TECHNOLOGY

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Triangulated instruments mimic a multi-port approach THE TECHNIQUE

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Scaled, tremor-reduced movement THE TECHNIQUE

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Cadiere

Grasper

Clip

Applier

Cautery

Hook Scissors

Suction

Irrigator

Crocodile

Grasper

Fundus

Grasper

Bipolar

Maryland

Needle

Driver

Fenestrated

Bipolar

Full hysterectomy instrument suite available THE TECHNIQUE

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3DHD vision provides detailed view of critical anatomy THE TECHNIQUE

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Autonomous, ergonomic control of instruments and camera THE TECHNIQUE

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NEW Curved Needle Driver will enable intracorporeal suturing THE TECHNIQUE

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THE RESULT Virtually scarless results1,5

Minimal pain5,6

Low blood loss5

Fast recovery6

Short hospital stay5,6

High patient satisfaction6

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Potential risks of any hysterectomy include:

• Blocked lung artery9

• Urinary tract injury9

• Blocked bowel9

• Pelvic abscess9

• Wound infection9

Additional risk of a hysterectomy with Single-Site technology may include:

• Research suggests there may be an increased risk of incision-site hernia with single-incision surgery.10,11

RISKS & CONSIDERATIONS Related to Hysterectomy, including da Vinci Single-Site Surgery

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1. Haber GP, White MA, Autorino R, Escobar PF, Kroh MD, Chalikonda S, Khanna R, Forest S, Yang B, Altunrende F, Stein RJ, Kaouk JH. Novel robotic da Vinci instruments for laparoendoscopic single-site surgery. Urology. 2010 Dec;76(6):1279-82. Epub 2010 Oct 27. 2. Rawlings A, Hodgett SE, Matthews BD, Strasberg SM, Quasebarth M, Brunt LM. Single-incision laparoscopic cholecystectomy: initial experience with critical view of safety dissection and routine intraoperative cholangiography. J Am Coll Surg. 2010 Jul;211(1):1-7. Epub 2010 Apr 28. 3. Badani KK, Bhandari A, Tewari A, Menon M. Comparison of two-dimensional and three-dimensional suturing: is there a difference in a robotic surgery setting? J Endourol. 2005 Dec;19(10):1212-5. 4. Allemann P, Leroy J, Asakuma M, Al Abeidi F, Dallemagne B, Marescaux J. Robotics may overcome technical limitations of single-trocar surgery: an experimental prospective study of Nissen fundoplication. Arch Surg. 2010 Mar;145(3):267-71. 5. Kroh M, El-Hayek K, Rosenblatt S, Chand B, Escobar P, Kaouk J, Chalikonda S. First human surgery with a novel single-port robotic system: cholecystectomy using the da Vinci Single-Site Platform. Surg Endosc. 2011 Nov;25(11):3566-73. Epub 2011 Jun 3rd. 6. Wren SM, Curet MJ. Single-port robotic cholecystectomy results from a first human use clinical study of the new da Vinci Single-Site surgical platform. Arch Surg, Jun 2011; doi: 10.1001/archsurg.2011.143 7. PN 1005085rA: Amanda Fader, MD. John’s Hopkins Hospital, Baltimore MD. Available at https://www.davincisurgerycommunity.com as part of side by side comparison PN1001330. 8. PN 1001330rA: Thomas Payne, MD, Devin Garza MD. North Austin Medical Center, Austin TX Available at https://www.davincisurgerycommunity.com as part of side by side comparison PN1001330. 9. Landeen LB, Bell MC, Hubert HB, Bennis LY, Knutsen-Larson SS, Seshadri-Kreaden U. Clinical and cost comparisons for hysterectomy via abdominal, standard laparoscopic, vaginal and robot-assisted approaches. S D Med. 2011 Jun;64(6):197-9, 201, 203 passim. 10. Ma, June, et al. Randomized Controlled Trial Comparing Single-Port Lap and Four-Port Lap Cholecystectomy. 2011, Annals of Surgery, Vol 254, Number 1, July 2011 11. Phillips, Melissa, et. al. Intermediate results of a prospective randomized controlled trial of traditional four-port lap cholecystectomy versus single-incision lap cholecystectomy. 2012, Surgical Endoscopy. 26:1296-1303

REFERENCES

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LABELING INFORMATION Serious complications may occur in any surgery, including da Vinci® Surgery, 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. Individual surgical results may vary. Risks specific to minimally invasive surgery, including da Vinci® Surgery, 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. You should discuss your surgical experience and review these and all risks with your patients, including the potential for human error and equipment failure. Physicians should review all available information. Clinical studies are available through the National Library of Medicine at www.ncbi.nlm.nih.gov/pubmed. Be sure to read and understand all information in the applicable user manuals, including full cautions and warnings, before using da Vinci products. Failure to properly follow all instructions may lead to injury and result in improper functioning of the device. 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. Procedure descriptions are developed with, reviewed and approved by independent surgeons. Other surgical techniques may be documented in publications available at the National Library of Medicine. For Important Safety Information, indications for use, risks, full cautions and warnings, please also refer to www.davincisurgery.com/safety and www.intuitivesurgical.com. Unless otherwise noted, products featured are available for commercial distribution in the U.S. For availability outside the US, please check with your local representative or distributor.

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LABELING INFORMATION Instrument & Accessory Care 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. The 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’s Manual. Single-Site® Cholecystectomy and Single-Site® Hysterectomy and Salpingo-oophorectomy for Benign Conditions Single-Site® Instruments for the da Vinci® Si™ System bear the CE mark. This device is cleared for commercial distribution in the U.S. for laparoscopic cholecystectomy, and for hysterectomy and salpingo-oophorectomy for benign conditions. The Intuitive Surgical® da Vinci® Single-Site® Instruments and Accessories used with the da Vinci® Si™ Surgical System are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single-incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the Single-Site Port. The safety and effectiveness of Single-Site® Instrumentation for use in the performance of general laparoscopic abdominal and pelvic surgery procedures have not been established. There may be an increased risk of incision-site hernia with single-incision surgery.

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LABELING INFORMATION

© 2014 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders. PN 1001332 rev B 09/14