Signia™ Stapling System

Intelligent surgical stapling — a wise choice

The Signia™ stapling system is a powered surgical stapler equipped with Adaptive Firing™ and Adaptive Compression™ technologies.^†,1–3 Together, these technologies can sense tissue thickness and adjust clamping force and firing speed in real time.^†,1–3 By providing real-time feedback,^4–6 the system delivers stronger, more consistent staple lines.^†,‡,7,8 The powered handle ergonomics offers easy-to-reach push-button controls^§,9,10 and supports a braod range of adapters and reloads to meet a variety of procedural needs.

Signia™ circular stapler with Tri-Staple™ technology

Indications, Safety, and WarningsIndications for useThe Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single-use reloads, has applications throughout the alimentary tract for the creation of end-to-end, end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries. The intended purpose of the device is creation of anastomosis. ContraindicationsRefer to the Instructions for Use provided with the Signia™ stapling system User Manual for specific indications, contraindications, warnings, and precautions. Refer to the Instructions for Use provided with the Tri-Staple™ 2.0 circular reloads for specific indications, contraindications, warnings, and precautions. Warnings

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 attach an adapter to the power shell prior to inserting a Signia™ power handle.

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

Depending upon the potential failure mode for the stapler, an alternate opening procedure described in the Signia™ stapling system User Manual may or may not be successful in retracting the knife and unclamping the device to facilitate removal. Professional experience should be used to assess patient status when deciding the best course of action.

Avoid handling the top rim of the cartridge on the Tri-Staple™ 2.0 circular reload to prevent possible injury from the circular knife.

When using different lumen size reloads, ensure that the anvil and reload lumen sizes match.

The Signia™ circular adapter is provided NON-STERILE. Clean and sterilize before each use.

The Tri-Staple™ 2.0 circular reloads are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.

The Tilt-Top™ anvil is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.

The introducer is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.

The irrigation channel is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.

Powered shell is provided STERILE and is intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE.

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.

The device contains nickel that may cause allergic reaction.

Precautions

The stapler and adapters are to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. 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 User Manual for specific indications, contraindications, warnings, and precautions.

Select the Tri-Staple™ 2.0 circular 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 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.

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 gamma sterilization 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. Remove all traces of blood and surgical debris by wiping down the adapter. Reprocess as soon as possible following use. If reprocessing cannot be performed within one hour rinse with at least 50ml of water through the flush port.

To remove a reload wait three seconds after any motor movement before disconnecting the reload from the adapter.

When attaching a new reload, make sure that the adapter is clean of debris. Debris can prevent the contacts between the adapter and the reload from properly connecting and the system will not recognize the reload. If this happens, remove the reload and clean the adapter contacts and then reconnect the reload. If the reload cannot be recognized, then the adapter is too dirty and must be sent for a full cleaning and a new adapter must be used.

To remove an adapter wait three seconds after any motor movement before disconnecting the adapter from the power pack.

Compatibility of other manufacturer’s staples and staplers has not been determined. LIMITATIONS ON PROCESSING Covidien has reliability studies for these devices for up to 50 procedural uses. The circular adapter is a reusable device and will deactivate after reaching the end of its service life. The device will not deactivate during use. The device number of uses remaining indication is provided on the display. ADVERSE REACTIONS While every attempt has been made to reduce patient and user risks, all surgeries using this device carry some residual risk, even when used by trained physicians. The potential adverse reactions associated with the use of the Signia™ stapling system consisting of the Signia™ circular adapters and Tri-Staple™ 2.0 circular reloads are: unspecified infection, hypersensitivity/allergic reaction, fistula, failure to anastomose, hemorrhage/blood loss/bleeding, peritonitis, sepsis, hemothorax, bowel burn, ischemia, stenosis, foreign body in patient, perforation, bowel perforation, environmental contamination, gastro-intestinal obstruction/occlusion, tissue breakdown. 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.

Signia™ linear stapler with Tri-Staple™ technology

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.

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.

Signia™ circular stapler with Tri-Staple™ 2.0 reloads

Signia™ intelligence meets Tri-Staple™ 2.0 technology to create a circular stapler unlike any other.

Empowered anastomotic performance

The Signia™ circular stapler combines powered, intelligent clamping and firing with trusted Tri-Staple™ technology to introduce an innovative new generation of stapling device to colorectal and general surgery.

Signia™ circular stapler with Tri-Staple™ technology

Pair circular adapters and reloads with the Signia™ stapling system to create confident anastomoses backed by Tri-Staple™ technology.

View product details

Less tissue stress

Adaptive Compression™ technology provides real-time feedback,^2,3 allowing you to apply just the right amount of compression.

The result is less stress on tissue,^{‡ ‡,21,22} reduced user variability,^§§,23 and increased consistency^◊◊,23 while creating anastomoses.

Greater perfusion

With greater perfusion^¶¶,24 and more protection against anastomotic leaks,^##,25 you can rely on the Signia™ circular stapler to deliver a confident staple line^{∆∆,∞∞,23,26} while improving patient outcomes and recovery.^{†††,24,27,28}

The Signia™ stapling system is ready to support you and your patients across a variety of procedures.

Signia™ linear stapler with Tri-Staple™ technology
Explore an array of linear stapling adapters and reloads, all powered by Signia™ intelligence and Tri-Staple™ performance.

View product details

How does the Signia™ stapling system perform in robotic-assisted surgery (RAS) procedures?

Medtronic bedside staplers

17.2
times fewer ICU visits

than robotic staplers (SureForm™* staplers)^‡‡‡

See RAS bedside stapling evidence

Meet clinical challenges with confidence.

Bariatric surgery

Tackle variable tissue with confidence.

With unique design features, stapling reloads with Tri-Staple™ technology deliver superior performance across a broad range of thicknesses.^{‡,∆,12,15–18}

View bariatric surgery solutions.

Colon and rectal surgery

Maximize blood flow,^∞,19 maximize confidence.

Tri-Staple™ technology’s graduated compression profile and varied height staples allow greater perfusion into the staple line.^∞,19

Learn about colon and rectal surgical products.

Thoracic surgery

Manage stress, increase confidence.

Tri-Staple™ technology provides superior strength and leak resistance^{¶,◊,#,13,14,16,20} while generating less stress on tissue during compression and clamping.^{∞,††16,20}

Explore thoracic surgery solutions.

Resources

View the Signia™circular stapler information sheet.

Signia™ Circular Stapler Information Sheet (open in new window)

Get an overview of key features and benefits of the Signia™ circular stapler.

PRODUCT PDF 747 KB

Signia™ Circular Stapler Competitive Comparison Infographic (open in new window)

View an infographic detailing advantages the Signia™ circular stapler has over our leading competitor.

COMPETITIVE PDF 1 MB

View the Signia™ stapling system information sheet.

Signia™ Stapling System Information Sheet (open in new window)

Experience the Signia™ stapling system — a powered surgical stapler equipped with Adaptive Firing™ and Adaptive Compression™ technologies.

PRODUCT PDF 2 MB

Signia™ Stapling System Value Analysis Brief (open in new window)

View a guide detailing the benefits of the Signia™ stapling system.

PRODUCT PDF 12 MB

View the Signia™ stapling system versus Ethicon Echelon™* 3000 competitive comparison information sheet.

Signia™ Stapling System Versus Ethicon Echelon™* 3000 Competitive Comparison Information Sheet (open in new window)

Learn more about how the Signia™ stapling system performs against the Ethicon powered platform.

CLINICAL EVIDENCE PDF 17 MB

Signia™ Stapling System Cleaning and Sterilization Guide (open in new window)

View a cleaning and sterilization guide for the Signia™ stapling system, including steps for cleaning both linear and circular adapters.

EDUCATION AND TRAINING PDF 1 MB

View a comprehensive brochure about the value of the Signia™ circular stapler.

Signia™ Circular Stapler Value Analysis Brochure (open in new window)

View a comprehensive brochure on the Signia™ circular stapler to share with a hospital’s Value Analysis Board.

PRODUCT PDF 6 MB

Signia™ Circular Stapler Quick-Use Instructional Guide (open in new window)

View an instructional tip card for how to use the manual retract tool and adapter.

EDUCATION AND TRAINING PDF 1 MB

Brochure of FAQ's for Signia™ circular stapler

Signia™ Circular Stapler FAQ Brochure (open in new window)

View a frequently asked questions for Signia™ circular stapler brochure.

EDUCATION AND TRAINING PDF 1 MB

Our diverse array of Tri-Staple™ reloads are designed for a variety of applications and surgical specialties.

TM* Third-party brands are trademarks of their respective owners.

† Preclinical results may not correlate with clinical performance in humans.

‡ Compared to manual and fixed-speed powered staplers.

§ 38 out of 38 surgeons surveyed agreed.

◊ Compared to manual staplers EES Echelon Flex™* stapler during placement.

¶ Bench test results may not necessarily be indicative of clinical performance.

# 23 out of 23 surgeons surveyed agreed.

∆ Bench test results may not necessarily be indicative of clinical performance. Compared to Ethicon Echelon Flex™* stapler.

∞Compared to flat-faced cartridges with single-height staples.

†† Compared to Echelon Flex™* green reloads analysis comparing different stapler designs, performance, and impact on tissues under compression using 2D finite element analysis.

‡ ‡ Bench test results may not necessarily be indicative of clinical performance. Compared to EEA™ circular staplers with DST Series™ technology (EEA2835, p < 0.001, n = 5), Ethicon™* CDH (CDH29A n = 9 , p <0.001, n = 5 for SIGCIR, for CDHA), and Ethicon Echelon Circular™* powered stapler (Ethicon™* CDH29P,p < 0.001, n = 5).

§§ Based on survey results from trained surgeons using Signia™ circular stapler. 14 out of 16 surgeons agree.

◊ ◊ Based on survey results from trained surgeons using Signia™ circular stapler in regards to circular anastomosis creation. 16 out of 16 surgeons agreed.

¶¶ Compared to the Ethicon Circular™* powered stapler in an in vivo benchtop comparison (CDH31P: n = 13; SIGCIR31XT: n = 9, p = 0.043). Results may not correlate with clinical performance in humans.

## Preclinical results may not correlate with clinical performance in humans. Based on leak testing in an in vivo canine model comparing to Ethicon Circular™* powered stapler. (SIGCIR28MT: n = 18; CDH29P:n = 14; p = 0.04).

∆∆ Based on survey results from trained surgeons comparing CDH31P to SIGCIR31XT (n = 15, p = 0.008).

∞∞ Based on survey results from trained surgeons using Signia™ circular stapler. 16 out of 16 surgeons agreed.

††† The Signia™ circular stapler allows 164% greater perfusion into the staple line than the Echelon Circular™* powered stapler, which may facilitate better wound healing at the anastomotic site. Compared to theEthicon Circular™* powered stapler in an in vivo benchtop comparison (CDH31P: n = 13; SIGCIR31XT: n = 9, p = 0.043). Results may not correlate with clinical performance in humans.

‡ ‡ ‡ When fired in indicated porcine tissue thickness. Preclinical testing may not be indicative of clinical performance.

Signia™ stapling system

Intelligent surgical stapling — a wise choice