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FBO DAILY ISSUE OF JULY 30, 2009 FBO #2803
SOLICITATION NOTICE

65 -- DA VINCI SI SYSTEM

Notice Date

7/28/2009
 

Notice Type

Presolicitation
 

NAICS

339112 — Surgical and Medical Instrument Manufacturing
 

Contracting Office

Department of Veterans Affairs;VA Boston Healthcare System;Contracting Officer (90C);940 Belmont Street;Brockton MA 02301
 

ZIP Code

02301
 

Solicitation Number

VA-241-09-RP-0385
 

Response Due

8/10/2009
 

Archive Date

10/9/2009
 

Point of Contact

Christine GormanContract Specialist<br />
 

E-Mail Address

Christine.Gorman@Va.gov
(Christine.Gorman@va.gov)
 

Small Business Set-Aside

N/A
 

Description

Monday, July 27, 2009 Pursuant to FAR 6.302-1, The Department of Veterans, VA Boston Healthcare System, has a requirement from Intuitive Surgical Inc., located in 950 Kifer Road, Sunnyvale, CA 94086-5206 to provide: SCOPE OF WORK 1. daVinci Si Surgical System. Intuitive's da Vinci Si HD Surgical System integrates 3D HD endoscopy and state-of-the-art robotic technology to virtually extend the surgeon's eyes and hands into the surgical field. Only this system enables new, minimally invasive options for complex surgical procedures. This equipment will offer new technology of robot assisted minimally invasive surgically procedures to veterans which currently are not available. This equipment will have extensive use for treatment of prostate cancer in urology as well as other urologic and non-urologic procedures. The da Vinci Surgical System includes advanced 3D HD visualization with up to 10x magnification, offering surgeons an immersive view of the operative field, superior to that offered by conventional surgical approaches. The EndoWrist instrumentation provides surgeons with natural dexterity and range of motion far greater than a human hand. The Intuitive motion technology replicates the operative experience and control of open surgery by preserving natural eye-hand-instrument alignment and intuitive instrument control. Features and Benefits Enhanced 3D HD Vision 1080i equivalent, lightweight, intelligent camera head Dual Console Capability Exchange of instrument arm and endoscope control between surgeons Upgraded Surgeon Console Multi-function energy control Integrated touchpads controls Comprehensive ergonomic settings Expanded Fingertip Controls Seamless master controller repositioning Camera focus and zoom OR Integration Boom-compatible vision system Upgradeable architecture 1.3Service: The price for services for the daVinci si Surgical System, after the one year warranty. 1.4.FDA Requirement. The System shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. 2. ADDITIONAL TERMS AND CONDITIONS. 2.1. Government Obligations. (a)Use of System. The Government shall ensure that the System will be used only for its intended purpose, specifically minimally invasive surgery. Government will use the System only with surgical instruments and accessories made or approved by Intuitive, and shall not, nor shall Government permit any third party to, modify, disassemble, reverse engineer, alter or misuse the System, instruments or accessories. Such prohibited actions shall include, but shall not be limited to: (i) adding to, or subtracting from the System, any Government or third party equipment, hardware, firmware or software, or (ii) reconfiguring any of the Intuitive equipment, hardware, firmware or software as originally provided to Government as part of the System, without the express written permission from Intuitive. In addition, Government shall be liable for any and all damages, whether foreseeable, consequential or incidental, incurred by Intuitive and arising or resulting, directly or indirectly, from Government's breach of the above prohibition against modification, disassembly, reverse engineering, alteration or misuse of the System, instruments or accessories. Government shall ensure that the System is moved and/or operated only by trained personnel in accordance with the Documentation and Intuitive's instructions. In the event Government fails to comply with the requirements of this Section, Intuitive may terminate this Agreement immediately upon written notice and any warranties applicable to the System shall become void. (b)Disposal. Government shall assume the responsibility for properly disposing of all medical instruments, devices, and systems related to the operation and function of the System and accessories being acquired under this Agreement in accordance with the then current local environmental and safety laws and standards 2.2. Software Licenses and Restrictions. (a)Software License. Software embedded within the System is provided under license and is not sold to Government. Subject to the terms and conditions of this Agreement, Intuitive grants to Government a non-exclusive, non-transferable, fully paid, restricted use license to use the Software solely as incorporated in the System in machine-executable object code form and solely in connection with the operation of the System as described in the Documentation. Government shall not use, copy, modify or transfer the Software or any copy thereof, in whole or in part, except as expressly provided in this Agreement. In addition, Government shall not reverse engineer, decompile, disassemble, and attempt to derive the source code for, or otherwise manipulate the Software. Notwithstanding the foregoing, manipulation of the Software is permitted if, and then only to the extent that, the foregoing prohibition on manipulation is required to be modified by applicable law; provided, however, that Government must first request from Intuitive the information to be sought from the Software, and Intuitive may, in its discretion, provide such information to Government under good faith restrictions, and/or impose reasonable conditions on such use of the Software. Government acknowledges and agrees that the structure and organization of the Software are valuable trade secrets of Intuitive and Government agrees to protect the Software as Intuitive's Proprietary Information. Intuitive reserves all rights to the Software not expressly granted to Government herein. (b)Instruments and Accessories. Instruments and Accessories for the System shall be made available to Government from Intuitive pursuant to separate orders placed by Government to Intuitive. Government acknowledges and agrees that all Intuitive surgical instruments Government obtains from Intuitive are pursuant to a limited license to use those instruments with, and prepare those instruments for use with, the System. This license expires once an instrument is used up to its maximum number of uses as set forth in the documentation accompanying such instruments. Any other use of an Intuitive instrument, whether before or after the instrument's license expiration, including repair, refurbishment or reconditioning, is prohibited. 3.DELIVERY/ACCEPTANCE AND WARRANTY. (a)Delivery / Acceptance. The System shall be deemed accepted by Government upon delivery, installation, and completed testing on site at the Government's designated location ("Acceptance") as evidenced by Government execution of Contractor's delivery acceptance letter. (b)System Warranty. Contractor warrants to Government that the System as delivered will be free and clear of all liens and encumbrances (except as otherwise set forth in this Agreement) and, for the period of one (1) year from the Acceptance date will be free from defects in material and workmanship and will conform in all material respects to the Documentation when used in accordance with the Documentation and Contractor's instructions. Contractor's obligations under this warranty are limited to the repair or, at Contractor's option, replacement of all or part of the System. This warranty is void with respect to any claims arising from (i) any installation, repair, adjustments, modification, disassembly, alteration, reconfiguration, addition to, subtraction from, or misuse of the System by Government or any third party without the express written permission of Contractor; (ii) the System, to the extent Government has not operated, repaired or maintained the System in accordance with any reasonable handling, maintenance or operating instructions supplied by Contractor, or to the extent Government has used the System with surgical instruments or accessories that are not made or approved by Contractor; or (iii) the System to the extent that Government or Government's employee, agent, or contractor has subjected it to unusual physical or electric stress, misuse, abuse, negligence or accident. It is the Government's intention to solicit and negotiate only with this source. Please refer to the Sole Source Justification. This is not a solicitation; it is notice of intent to sole source a requirement. Inquires/information received after established deadline of Monday, August 10, 2009, 2009 1200 shall not be considered. The submission of any data for review shall not impede award of this contract as planned. The Government does not intend to pay for information solicited. This notice is issued pursuant to FAR 6.302-1. The Solicitation will be posted on FBO on/about Wednesday, August 12. 2009 at 1200 EST. However, any firm that believes it can meet these requirements may give written notification to the Contracting Officer within fifteen (15) calendar days from the date of publication of this notice. Supporting evidence must be furnished in sufficient detail, to demonstrate the ability to comply with the above requirements. This information can be faxed to Christine Gorman at 774-826-3347 or via e-mail to Christine.Gorman@va.gov. Responses will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon responses to this notice is solely within the discretion of the Government. Post on FBO on Monday, July 27, 2009 at 1600. Deadline on Tuesday, August 11, 2009 at 1600. JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION 1.Identification of (1) the agency (2) the contracting activity. VA Boston Healthcare System, Surgical Service, Operating Room, West Roxbury Campus 2.Nature and/or description of the action being approved. Procurement of the Da Vinci Si System 3.Description of the supplies or services required to meet the agency's needs (including the estimated value). Transaction Number: 523-09-4-4983-0040 The da Vinci Surgical System is the only commercially available technology that can provide the surgeon with the precision, dexterity and control of traditional open surgery while only requiring 1-2 cm incisions. It offers new technology of robot assisted minimally invasive surgical procedures to veterans which currently are not available. This will have extensive use for treatment of prostrate cancer in urology as well as other urologic and non-urologic procedures. 4.An identification of the statutory authority permitting other than full and open competition. FAR 6.302-1, Only one responsible source. 5.A demonstration that the proposed contractor's unique qualification or the nature of the acquisition requires use of the authority cited. Intuitive's da Vinci Surgical System integrates three dimensional, high definition endoscopy and state-of-the-art robotic technology. The system consists of an ergonomically designed surgeon's console, a patient cart with four interactive robotic arms and a high-performance vision system. This robotic device allows the surgeon to take surgical precision and technique beyond capabilities of the human hand by enabling and improving minimally invasive surgical procedures. The unit gives the surgeon the ability to operate laparoscopically using a 3-dimensional image, unlike the 2-dimensional image seen in standard laparoscopic surgery. Only this system offers new, minimally invasive options for complex surgical procedures. This system features wristed instruments with seven degrees of freedom, three dimensional, intuitive visualization and ergonomic comfort. It is the only commercially available technology that can provide the surgeon with the precision, dexterity and control of traditional open surgery, while only requiring 1-2 cm incisions. 6.Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a FedBizOps notice was or will be published as required by Subpart 5.2 and, if not, which exception under 5.202 applies. There are no similar devices that provide minimally invasive options, wristed instruments with seven degrees of freedom, three dimensional, intuitive visualization and ergonomic comfort. 7.A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable. The Contracting Officer determined that the anticipated cost to the Government is fair and reasonable. 8.A description of the market research conducted (i.e., names of firms and the date(s) the firms were contacted) and the results or a statement of the reasons a market survey was not conducted. The da Vinci Surgical System is the only device of its kind on the market; the most advanced platform for minimally invasive surgery available today. 9.Any other facts supporting the use of other than full and open competition, such as an explanation why technical data packages, specification, engineering description, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not available. This is the only known source that is capable of following our specification for this product. 10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition. N/A 11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. This contracting activity will continue to encourage full and open competition whenever possible. The Contracting Officer will work closely with the Service to look for the similar equipment in the Open Market.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/BoVAMC/VAMCCO80220/VA-241-09-RP-0385/listing.html)
 

Place of Performance

Address: Department of Veterans Affairs;VA Boston Healthcare System;West Roxbury Campus;1400 VFW Parkway, Bldg 2, 3rd Floor;West Roxbury MA<br />

Zip Code: 02132<br />
 

Record

SN01890716-W 20090730/090729000854-f7907dc2901d6f315f5e7fb6da04db83 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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