Medtronic SIGC60VM Instructions for Use

Signia™

Intelligent Loading Units and Tri-Staple™ 2.0
Intelligent Cartridges

PT00167987

D

B

A

C

F

H

I

G

F

J K L

2.0

Gray

45 mm

45 mm

45 mm

45 mm

60 mm

60 mm

60 mm

60 mm

BEFORE USING PRODUCT, READ THE FOLLOWING INFORMATION THOROUGHLY.

IMPORTANT!

This booklet is designed to assist in using this product. It is not a reference to surgical techniques.

This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may
lead to its failure and subsequent patient injury. Reuse, reprocessing and/or resterilization of this device may create the risk
of contamination and patient infection. Do not reuse, reprocess or resterilize this device.

DESCRIPTION

The Signia™ intelligent loading units and Tri-Staple™ 2.0 intelligent cartridges place staggered rows of titanium staples and
simultaneously divides the tissue so that three staggered rows of staples are placed on either side of the cut line. The size of
the staples is determined by the selection of the single use cartridge:

Tri-Staple™ 2.0 extra thin/vascular intelligent cartridge:

Gray - three rows of 2.0 mm titanium staples on either side of the cut line.

Tri-Staple™ 2.0 vascular/thin intelligent cartridge:

White - three rows of 2.5 mm titanium staples on either side of the cut line.

Tri-Staple™ 2.0 vascular/medium intelligent cartridge:

Tan - three height progressive rows of 2.0 mm, 2.5 mm, 3.0 mm titanium staples on either side of the cut line.

Tri-Staple™ 2.0 medium/thick intelligent cartridge:

Purple - three height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the cut line.

The Tri-Staple™ 2.0 intelligent cartridge is available in 45 mm and 60 mm lengths.

The Signia™ intelligent loading unit is available in articulating 45 mm and 60 mm lengths. Tri-Staple™ 2.0 intelligent
cartridges are able to be loaded into the Signia™ intelligent loading unit. Signia™ intelligent loading units may be used up
to twelve times in the same procedure.

CAUTION: Do not use the loading unit more than 12 times for a maximum of 12 firings per loading
unit. The use of the cartridge with staple line reinforcement material may reduce the number of
firings.

Ensure that the cartridge length matches the loading unit length prior to use.

All loading units fit through a 12 mm trocar sleeve or larger, with the use of a converter.

The Signia™ intelligent loading units and Tri-Staple™ 2.0 intelligent cartridges will contain an intelligence chip. The
intelligence chip will have the ability to communicate with the Signia™ stapler with Signia™ linear adapters.

White

Tan

Purple

Gray

White

Tan

Purple

mm

2.5

mm

3

mm

4

mm

2.0

mm

2.5

mm

3

mm

4

mm

E

E

M

2.0

2.0
mm

mm

2.5

mm

2.5

mm

3.5

mm

2.0

mm

2.5

mm

2.5

mm

3.5

mm

2.5

mm

mm

mm

2.0

mm

2.5

mm

mm

mm

2

3

2

3

.75 - 1.0 mm

1.0 - 1.5 mm

.88 - 1.8 mm

1.5 - 2.25 mm

.75 - 1.0 mm

1.0 - 1.5 mm

.88 - 1.8 mm

1.5 - 2.25 mm

STAPLER HANDLE COMPATIBILITY

The Signia™ intelligent loading unit can be used with the GIA™ universal stapler, Endo GIA™ universal staplers, Endo GIA™ Ultra
universal staplers, iDrive™ Ultra powered stapler with Endo GIA™ adapters and Signia™ stapler with Signia™ linear adapters.

Refer to the Instructions for Use for the GIA™ universal stapler, Endo GIA™ universal staplers, Endo GIA™ Ultra universal staplers,
iDrive™ Ultra powered stapler with Endo GIA™ adapters and Signia™ stapler with Signia™ linear adapters for specific indications,
contraindications, warnings, precautions, and operating instructions.

Refer to the Instructions for Use for the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra Universal, iDrive™, and Signia™
platforms for articulation angles.

Bioabsorbable staple line reinforcements such as GORE™* SEAMGUARD™* Bioabsorbable Staple Line Reinforcement and Baxter
Peri-Strips Dry™* Staple Line Reinforcement materials have been tested for use with Signia™ Intelligent Loading Units, Tri-Staple™ 2.0
medium/thick intelligent cartridges (Purple) and Tri-Staple™ 2.0 vascular/medium intelligent cartridges (Tan).

Compatibility of other manufacturer’s staple line reinforcement material for use with the Tri-Staple™ 2.0 extra thin/ vascular intelligent
cartridge (Gray) and the Tri-Staple™ 2.0 vascular/ thin intelligent cartridge (White) has not been determined.

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

INDICATIONS

The Signia™ intelligent loading units and Tri-Staple™ 2.0 intelligent cartridges have applications in abdominal, gynecologic, pediatric
and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver
substance, hepatic vasculature and biliary structures, and for transection and resection of pancreas.

CONTRAINDICATIONS

1. Do not use the Tri-Staple™ 2.0 extra thin/vascular intelligent cartridge (gray) on any tissue that compresses to less than 0.75 mm
in thickness, on any tissue that cannot comfortably compress to 1.0 mm or on the aorta.

2. Do not use the Tri-Staple™ 2.0 vascular/thin intelligent cartridge (white) on any tissue that compresses to less than 1.0 mm in
thickness, on any tissue that cannot comfortably compress to 1.5 mm or on the aorta.

3. Do not use the Tri-Staple™ 2.0 vascular/medium intelligent cartridge (tan) on any tissue that compresses to less than 0.88 mm in
thickness, on any tissue that cannot comfortably compress to 1.8 mm or on the aorta.

4. Do not use the Tri-Staple™ 2.0 medium/thick intelligent cartridge (purple) on any tissue that compresses to less than 1.5 mm in
thickness, on any tissue that cannot comfortably compress to 2.25 mm or on the aorta.

5. Tri-Staple™ 2.0 intelligent cartridges should not be used on friable or delicate tissue where the closure of the device might be
destructive to the tissues.

6. Do not use any linear cutter on major vessels without making provisions for proximal and distal control.

7. Do not use the instrument on ischemic or necrotic tissue.

8. These devices are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT
RESTERILIZE.

WARNINGS

1. Depending upon the stapler handle used, also refer to the applicable Instructions for Use for the GIA™ universal stapler, Endo GIA™
universal staplers, Endo GIA™ Ultra universal staplers, iDrive™ Ultra powered stapler with Endo GIA™ adapters and Signia™ stapler
with Signia™ linear adapters for specific indications, contraindications, warnings, precautions, and operating instructions.

2. Ensure that the loading units and staple cartridges are compatible with the staplers.

3. As with all surgical staplers, surgeons should consider specific patient factors before deciding if the device is suitable for use. For
example, preoperative radiotherapy may result in changes to tissue. These changes may, for example, cause the tissue thickness
to exceed the indicated range for the selected staple size. Careful consideration should be given to any pre-surgical treatment the
patient may have undergone and to the corresponding selection of staple size.

4. Always select a cartridge with the appropriate staple size for the tissue thickness. Overly thick or thin tissue may result in
unacceptable staple formation.

5. Ensure tissue has not extended (extruded) beyond the tissue stop proximally. Tissue forced into the instrument beyond the tissue
stop may be transected without stapling.

6. When positioning the stapler on the application site, ensure that no unintended obstructions, such as clips or other similar
structures, are incorporated into the instrument jaws. Firing over an obstruction may result in incomplete cutting action and/or
improperly formed staples, which may result in poor hemostasis and/or leakage..

7. 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.

8. A thorough understanding of the principles involved in laser and electrosurgical procedures is essential to avoid shock and burn
hazards to both patient and operator(s), and damage to the instrument.

9. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.

10. Visually inspect prior to firing for inclusion of unintended anatomic structures within the staple line.

11. The instrument will cut and staple any structure included in the jaws. Use caution to ensure that only structures to be cut and
stapled are within the instrument jaws.

12. Failure to completely fire the loading unit/cartridge will result in an incomplete cut and/or incomplete staple formation, which
may result in poor hemostasis and/or leakage.

13. There is 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.

14. Tri-Staple™ 2.0 intelligent cartridges and Signia™ intelligent loading units are provided STERILE and are intended for use in a
SINGLE procedure only. DISCARD AFTER USE. DO NOT RESTERILIZE. Reprocessing or resterilization may compromise the device
integrity and could lead to patient injury, illness, or death. Reuse, even after resterilization, may create a risk of contamination and
lead to patient infection or the transmission of infectious disease(s).

PRECAUTIONS

1. Depending upon the stapler handle used, also refer to the applicable Instructions for Use for the GIA™ universal stapler, Endo GIA™
universal staplers, Endo GIA™ Ultra universal staplers, iDrive™ Ultra powered stapler with Endo GIA™ adapters and Signia™ stapler
with Signia™ linear adapters for specific indications, contraindications, warnings, precautions, and operating instructions.

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

3. Always include the combined thickness of the tissue and of any staple line reinforcement material in use when choosing the
proper staple cartridge.

4. When using a staple line reinforcement material, follow the instructions provided by the manufacturer of the staple line
reinforcement material, as performance of the stapler may be affected when using staple line reinforcement material.

5. When using a staple line reinforcement material, verify compatibility with access ports.

6. When using the Endo GIA™ Ultra universal stapler with a buttressed reload to grasp or manipulate target tissue
multiple times, the reinforcement material may move and/or dislodge.

7. Compatibility of other manufacturer’s staple line reinforcement material for use with the Tri-Staple™ 2.0 extra thin/
vascular intelligent cartridge (Gray) and the Tri-Staple™ 2.0 vascular/ thin intelligent cartridge (White) has not been
determined.

8. Do not attempt to remove the cartridge cover until the loading unit is loaded into the instrument.

9. Do not clamp instrument prior to removing cartridge cover.

10. Always close the jaws of the Signia™ intelligent loading unit loaded with the Tri-Staple™ 2.0 intelligent cartridge prior
to introducing and removing the stapler from the trocar sleeve or the incision. Do not attempt to insert or remove the
instrument from the incision or trocar sleeve if the instrument is in the articulated position.

11. After firing and removal of the instrument, always inspect the staple line and the surrounding site for hemostasis and/
or leakage. Minor bleeding may be controlled by electrocautery or manual sutures. Minor leakage may be controlled
by manual sutures.

12. Placement of tissue proximal to the tissue stops (on the reload) may result in stapler malfunction. Any tissue extending
beyond the cut line will not be transected.

13. Ensure tissue has not extended (extruded) beyond the tissue stop proximally. Tissue forced into the instrument beyond
the tissue stop may be transected without stapling.

14. The Tri-Staple™ 2.0 intelligent cartridges are single use. A safety interlock is provided that prevents an empty single use
cartridge from being fired a second time. Do not attempt to override the safety interlock. Overriding the safety interlock
will cause device malfunction.

15. Do not use the Signia™ intelligent loading unit more than 12 times for a maximum of 12 firings per loading unit. The
use of the cartridge with staple line reinforcement material may reduce the number of firings. The use of staple line
reinforcement material with the loading unit may require an increased firing force and may reduce the number of times
the device may be fired.

16. The instrument will not cut tissue beyond the black cut line indicated on the loading unit. More than one application of
the stapler may be necessary for tissue exceeding the length of the reload (45 mm or 60 mm).

17. When endoscopic instruments and accessories from different manufacturers are employed together in a procedure,
verify compatibility and ensure that electrical isolation or grounding is not compromised.

18. The anvil must be completely visible (having passed completely through the trocar sleeve) prior to opening the loading
unit within the body cavity.

19. When dividing major vascular structures, be sure to adhere to the basic surgical principles of proximal and distal control.

20. Do not load a used Tri-Staple™ 2.0 intelligent cartridge into a Signia™ intelligent loading unit.

21. Do not attempt to fire a used Tri-Staple™ 2.0 intelligent cartridge.

22. Do not attempt to load a Tri-Staple™ 2.0 intelligent cartridge of a length different than the Signia™ intelligent loading
unit. A Tri-Staple™ 2.0 intelligent cartridge of a length different from the Signia™ intelligent loading unit cannot be
loaded. Ensure that the cartridge length matches the loading unit length prior to use.

23. Prior to firing, ensure that the Tri-Staple™ 2.0 intelligent cartridge is completely embedded into the channel of the
Signia™ intelligent loading unit.

24. Do not try to load a Tri-Staple™ 2.0 intelligent cartridge in the Signia™ intelligent loading unit if the cartridge cover is
missing or misaligned.

25. Dispose of used instruments, used cartridges and used loading units in accordance with the end-user’s medical and
biological waste disposal requirements.

26. The titanium staples in this device are nonferromagnetic and may undergo MRI and/or NMR procedures at forces of 3.0
Tesla or less after implantation.

MRI INFORMATION

Non-clinical testing demonstrated that a representative titanium staple is MR Conditional. A patient with these titanium
staples can be scanned safely immediately after placement of the titanium staple under the following conditions:

• Static magnetic field of 1.5T and 3.0T

• Maximum spatial gradient magnetic field of 3000-Gauss/cm (30 T/m)

• Normal Operating Mode of operation for the MR system (whole body averaged SAR, 2-W/kg) for 15 minutes of
scanning, per pulse sequence.

Under the scan conditions defined above, the titanium staple is expected to produce a maximum temperature rise of less
than 3.2°C after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends approximately 2mm from the titanium staple when
imaged with a gradient echo pulse sequence and a 3.0T MRI system

ADVERSE REACTIONS

Possible adverse reactions and potential complications may include but are not limited to: seroma/hematoma, bleeding/
hemorrhage/leak, ischemia, chronic pain, infection, allergic reactions, inflammatory reaction, visceral adhesions, fistula,
nerve entrapment, tissue erosion and small bowel perforation, need for future reoperation.

SCHEMATIC VIEW

A) ANVIL

B) TISSUE STOP

C) LOWER CLAMP COVER

D) LOADING UNIT (45 or 60 mm lengths)

E) INTELLIGENCE CHIP

F) CARTRIDGE COVER

G) END OF STAPLE LINE

H) INCREMENT MARKINGS

I) END OF CUT LINE

INSTRUCTIONS

1. Load the Tri-Staple™ 2.0 intelligent cartridge into the Signia™ intelligent loading unit. Grasp each side of the loading
unit apex to ensure that the anvil and channel remain stable during loading. Insert the distal end of the cartridge
into the channel of the loading unit, starting at the first numbered hash mark. Ensure that the edges of the cartridge
are fully seated in the channel. Angle the yellow cover parallel to the anvil face and slide the cartridge down into
the channel. The cartridge will hit a stop in the loading unit channel when fully inserted. At this point, the square
locking feature at the tip of the cartridge should line up with the notch on the tip of the loading unit channel. When
successfully aligned, pinch the cartridge and channel together to snap the assembly in place. Proper assembly will be
confirmed with an audible and tactile snap.

CAUTION: Do not attempt to load a Tri-Staple™ 2.0 intelligent cartridge of a length different than
the Signia™ intelligent loading unit. Ensure that the cartridge length matches the loading unit
length prior to use.

2. Once the cartridge is loaded into the loading unit, remove the cartridge cover by pulling the proximal end away from
the seated cartridge gently with your finger. Do not discard the cartridge cover. The cartridge cover will help remove the
fired cartridge from the loading unit.

3. Depending upon the stapler handle used, refer to the Instructions for Use for the GIA™ universal stapler, Endo GIA™
universal staplers, Endo GIA™ Ultra universal staplers, iDrive™ Ultra powered stapler with Endo GIA™ adapters and
Signia™ stapler with Signia™ linear adapters for operating instructions.

4. After the cartridge has been fired, unload the cartridge from the Signia™ intelligent loading unit. Securely insert
the small tab at the tip of the cartridge cover into the corresponding pocket on the tip of the cartridge. Once the tab
is inserted, twist the cover ninety degrees to disengage the cartridge from the loading unit. Once the cartridge is
disengaged, it can be removed by sliding out of the loading unit.

CAUTION: Do not attempt to fire a used Tri-Staple™ 2.0 intelligent cartridge.

5. If a new firing is needed, insert a Tri-Staple™ 2.0 intelligent cartridge of the same length into the Signia™ intelligent
loading unit.

WARNING: Prior to reloading the loading unit, wipe the anvil and cartridge jaw to clear any formed
and unused staples from the loading unit. Do not reuse the loading unit until it has been visually
inspected to confirm there are no staples on the anvil and cartridge jaw.

The Signia™ intelligent loading unit may be reloaded and fired up to 12 times in a single procedure.

CAUTION: When using Signia™ intelligent loading units with the iDrive™ Ultra powered stapling
device, remove the loading unit from the Endo GIA™ adapter after firing is complete. If additional
firings are needed, re-attach the loading unit prior to inserting a new cartridge.

CAUTION: When used in conjunction with Signia™ linear adapters avoid submerging the loading
unit in sterile liquids as this may compromise communication with the cartridge.

CAUTION: The use of staple line reinforcement material with the loading unit may require an
increased firing force and may reduce the number of times the device may be fired.

STAPLE SPECIFICATIONS

J) STAPLE LINE LENGTH

K) COLOR

L) OPEN STAPLE SIZE

M) INTENDED TISSUE THICKNESS RANGE

Tissue

12

101.3 kPa

54.9 kPa

85%

en: Intended compressed tissue thickness

en: Maximum number of cartridges

en: Sterilized using ethylene oxide

en: Single Use

en: Caution: U.S. Federal law restricts this device to sale by or on the

order of a physician.

en: Do not resterilize

en: Do not use if package is damaged.

en: Consult instructions for use

en: Caution, consult accompanying documents

en: MR Conditional

en: Transport atmospheric pressure

en: Transport humidity limitations

140°F
60°C

-20.2°F

-29°C

94°F
34°C

63°F

17°C

C

B

A

en: Staple rows, staggered staple pattern

A

B

C

en: Open

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2022 - 07 / 03

en: Transport temperature limitations

en: Store at room temperature

en: Type CF applied part

en: Package quantity