Signia™ powered stapler with Tri-Staple™ technology angled view

Powered staplers

Signia™ linear stapler with Tri-Staple™ technology

<p>The Signia™ linear stapler includes Tri-Staple™ and Adaptive Firing™ technology within an intelligence-enabled powered handle featuring an OLED display screen.</p> <p> </p>

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Indications, Safety, and WarningsIndications for useThe Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with compatible single use staple reloads, reinforced reloads, loading units and cartridges has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It may be used for transection and resection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of pancreas. The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with compatible curved tip single use reloads can be used to blunt dissect or separate target tissue from other certain tissue. The Signia™ stapler composed of the Signia™ reusable power handle, Signia™ single use power shell and Signia™ reusable linear adapter, when used with compatible single use radial reloads has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e. low anterior resection. It may be used for transection and resection of liver substance, hepatic vasculature and biliary structures and for transection and resection of pancreas.ContraindicationsRefer to the Instructions for Use provided with the Signia™ stapling system’s user manual for specific indications, contraindications, warnings, and precautions.Warnings

The stapler and adapters are to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. Covidien™ stapling reloads are intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated.

Refer to the Instructions for Use provided with the Signia™ stapling system’s user manual for specific indications, contraindications, warnings, and precautions.

Select the Covidien™ stapling reload with an indicated tissue range that is appropriate for the target tissue. Overly thick or thin tissue may result in unacceptable staple formation.

The Signia™ linear adapter is a precise instrument. Care should be taken to avoid dropping. Improper handling, cleaning, or sterilization may shorten device service life and/or lead to device failure.

The Signia™ linear adapter is provided non-sterile. Clean and sterilize before each use.

Powered Shell is provided stero;e and is intended for use in a single procedure only. Discard after use. Do not resterilize.

Do not flash sterilize (immediate-use sterilize) the adapter.

Use only the sterilization method that is recommended and qualified for the adapter, as described in this document. Do not use hydrogen peroxide gas plasma technology (such as STERRAD™* systems) or gammasterilization to sterilize the adapter.

Clean the adapter immediately after use to prevent blood and other biological materials from drying on the surface of the device. Do not use abrasive agents.

Do not hold or carry the stapler by the distal end of the adapter, or by the stapling reload when an adapter is attached to the stapler.

Do not attempt to load a stapling reload before the adapter has been attached to the stapler and calibration has been completed. Doing so may lead to improper calibration and/or device damage.

Do not attach an adapter to the power shell prior to inserting a power handle into the power shell.

Do not load a reload onto the adapter prior to attaching onto a power handle. The stapler will not allow the stapling reload to fire until the reload is removed and the adapter completes its calibration.

Do not use the adapter if the packaging or the device appears damaged.

Endoscopic procedures should be performed only by physicians having adequate training and familiarity with endoscopic techniques. Prior to performance of any endoscopic procedures, consult the medical literature relative to techniques, complications, and hazards.

A thorough understanding of the principles involved in laser and electrosurgical procedures is essential to avoid shock and burn hazards to both patient and operators and damage to the instrument.

There is a risk of increased leak rates when staple lines are crossed, even if there may be clinical circumstances when a surgeon may deem it necessary or appropriate to do so.

Ensure that the staple reloads are compatible with the staplers.

Depending upon the potential failure mode for the stapler, an alternate opening procedure described in the Signia™ stapling system’s user manual may or may not be successful in retracting the knife and openinthe stapling reload. Professional experience should be used to assess patient status when deciding the best course of action.

Compatibility of other manufacturer’s staples and staplers has not been determined.

For all adverse reactions related to the Signia™ stapling system, refer to the Signia™ user manual.

In the event that a serious incident has occurred related to device use, immediately report the event to Covidien, the competent authorities, and any other regulators as required.

Avoid use of the device on the aorta.

Features

Experience the proven performance of Tri-Staple™ technology.

The Signia™ linear stapler:

Delivers consistent staple lines^†,3,4
Provides precision and maneuverability^◊,6 with fully powered articulation, rotation, and clamping^§,5
Displays real-time feedback on an LED screen to help you make informed decisions about your staple load selection^¶,7

Fewer malformed staples.^†,‡,1 Stronger staple lines.^†,‡,8

The Signia™ linear stapler is compatible with our existing reload portfolio featuring the proven performance of Tri-Staple™ technology. Compared to the Ethicon™* powered stapler with GST technology, its combination delivers:

Three times fewer malformed staples^†,1
50% stronger staple lines^†,8

Confident stapling in robotic-assisted surgery (RAS) procedures

The intelligent performance of Signia™ with Tri-Staple™ technology provides better staple formation than the da Vinci SureForm™* stapler.^#,9

Clinical evidence supporting use of bedside staplers

Fewer ICU visits¹⁰

Medtronic bedside staplers

17.2 times less
than robotic staplers (SureForm™* staplers)^∆

Less operative room time¹⁰

Medtronic bedside staplers

32 minutes less
than robotic staplers (SureForm™* staplers)^∆

Saving inpatient costs¹⁰

Medtronic bedside staplers

$2,670 USD less
than robotic staplers (SureForm™* staplers)^∆

See the evidence

Surgeon uses Signia™ stapling system bedside during a robotic-assisted surgery procedure

Less bleeding
Signia™ with Tri-Staple™ technology is 37% less likely to bleed than the SureForm™* robotic stapler^#,∞,9

Performance under pressure
Signia™ with Tri-Staple™ technology can withstand 20% greater leak pressure than the SureForm™* robotic stapler.⁹

More security
Signia™ with Tri-Staple™ technology delivers 114% greater staple line security than the SureForm™* robotic stapler.⁹

Download competitive comparison (open in new window)

What surgeons are saying about the hybrid approach

Dr. Allison discusses using the hybrid approach for bariatric surgery.

View a video of bedside stapling in a robotic-assisted sleeve gastrectomy using the Signia™ stapler with Tri-Staple™ technology. This surgery is performed by Dr. Lucian Panait of Minneapolis, Minnesota.

Clinical papers

Adaptive Firing™ technology

Check out our technical summary to learn more about the science behind adaptive firing™ technology — and how it works across different tissue conditions.

Development of Adaptive Firing™ Technology White Paper (open in new window)

View a technical summary describing the development of the Adaptive Firing™ technique.

CLINICAL EVIDENCE PDF 494 KB

Making the switch

A bariatric surgeon tells General Surgery News why he switched to the Signia™ stapler.

Dr. Wheeler Signia™ Tri-Staple Reloads Clinical Paper (open in new window)

Bariatric surgeon Andrew Wheeler, MD, shares with General Surgery News about why he uses our Signia™ stapler with Tri-Staple™ reloads in his procedures. This clinical paper was sponsored by Medtronic.

CLINICAL EVIDENCE PDF 279 KB

Bedside clinical summary

Review a clinical summary about the effectiveness of bedside staplers in bariatric robotic procedures.

Surgical Stapling — Effectiveness of Stapling in Bariatric Procedures Clinical Summary (open in new window)

Learn about the effectiveness of bedside staplers in bariatric robotic procedures.

CLINICAL EVIDENCE PDF 139 KB

Update your Signia™ power handle software.

The Valleylab™ Exchange (VLEX™) software update system enables you to update software on your Signia™ power handle. This ensures that you have access to the latest performance features as new features become available for your device.

Valleylab™ Exchange is a software application that you download, install, and run on your computer.

Valleylab™ Exchange software requirements:

Application is supported by Windows 10
Requires 9 GB free space
Recommended browser: Google Chrome™

Download and install Valleylab™ Exchange application software.

Download now (open in new window)

View license agreement

Ordering information

Item number	Description	Units per box
SIGPHANDLE	Signia™ power handle	1
SIGPSHELL	Signia™ power control shell	6
SIGADAPTSTND	Signia™ linear adapter	1
SIGADAPTXL	Signia™ linear adapter xl	1
SIGADAPTSHORT	Signia™ linear adapter short	1
SIGSBCHGR	Signia™ single-bay charger	1
SIGRIG	Signia™ reusable insertion guide	1
SIGMRET	Signia™ manual retraction tool	1
SIGTRAY	Signia™ sterilization tray	1
SIGPCORD1	Signia™ power cord 1 — United States of America	1
SIGPCORD6	Signia™ power cord 6 — Japan	1