Medtronic SIGRADMT Instructions for Use
Tri-Staple™ 2.0
Radial Reload
PT00167988
B
C
D
I J
Tan
Purple
Black
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.
These devices were designed, tested and manufactured for single patient use only. Reuse or reprocessing of these devices
may lead to their failure, subsequent patient injury, or death. Reprocessing and/or resterilization of these devices may
create the risk of contamination and patient infection. Do not reuse, reprocess or resterilize these devices.
DESCRIPTION
The Tri-Staple™ 2.0 radial reload places three radial (curved) staple rows 60 mm in length on each side of a cut line and
simultaneously divides the tissue between the third and fourth lines, creating a 60 mm curved transection. The size of the
staples is determined by the selection of the single use reload:
The single use Tri-Staple™ 2.0 radial reload vascular/ medium (tan) places height progressive titanium staple rows of 2.0
mm (nearest cut line), 2.5 mm and 3.0 mm.
The single use Tri-Staple™ 2.0 radial reload medium/ thick (purple) places height progressive titanium staple rows of 3.0
mm (nearest to cut line), 3.5 mm and 4.0 mm.
The single use Tri-Staple™ 2.0 radial reload extra thick (black) places height progressive titanium staple rows of 4.0 mm
(nearest to cut line), 4.5 mm and 5.0 mm.
The Tri-Staple™ 2.0 radial reload may be inserted through an access device such as a hand access device or comparable
access port.
The Tri-Staple™ 2.0 radial reload will contain an intelligence chip. The intelligence chip will have the ability to communicate
with Covidien™ powered stapler handles that have a compatible communications interface.
Radial reloads do not articulate.
STAPLER HANDLE COMPATIBILITY
The Tri-Staple™ 2.0 radial reloads are compatible with the following Covidien staplers: Endo GIA Universal, Endo GIA Ultra,
iDrive, and Signia platforms.
Some features of Signia are only compatible when used with Tri-Staple 2.0 single use reloads, Signia intelligent loading
units.
Refer to the respective IFUs of the stapler for complete information on the use of the devices.
Compatibility of other manufacturer’s staples and staplers has not been determined.
INDICATIONS
The Tri-Staple™ 2.0 radial reload has application 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, e.g. low anterior resection.
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 radial reload vascular/ medium (tan) on any tissue that compresses to less than .88 mm
in thickness, on any tissue that cannot comfortably compress to 1.8 mm or on the aorta.
2. Do not use the Tri-Staple™ 2.0 radial reload medium/ thick (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.
3. Do not use the Tri-Staple™ 2.0 radial reload extra thick (black) on any tissue that compresses to less than 2.25 mm in
thickness, on any tissue that cannot comfortably compress to 3.0 mm or on the aorta.
A
F
E
3mm2.5mm2
4
3.5mm3
mm
5mm4.5
mm4mm
H
G
K
mm
.88 - 1.8 mm
mm
1.5 - 2.25 mm
2.25 - 3.0 mm
4. Do not use the Tri-Staple™ 2.0 radial reload on any portion of the aorta, the coronary, carotid, or pulmonary arteries or veins, the
superior or inferior vena cava, common, internal or external iliac arteries or veins and the brachiocephalic trunk.
5. The Tri-Staple™ 2.0 radial reload 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 the Tri-Staple™ 2.0 radial reload where adequacy of hemostasis cannot be verified visually.
7. Do not use any cutting stapler on major vessels without making provisions for proximal and distal control.
8. Do not use on ischemic or necrotic tissue.
WARNINGS
1. Depending upon the stapler handle used, refer to the applicable Instructions for Use for the GIA™ universal stapler, Endo GIA™
universal staplers, Endo GIA™ Ultra universal staplers and powered stapler handles used with Endo GIA™ adapters for specific
indications, contraindications, warnings, precautions, and operating instructions.
2. 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 in corresponding selection of staple size.
3. Always select a reload with the appropriate staple size for the tissue thickness. Overly thick or thin tissue may result in
unacceptable staple formation.
4. Inspect the cartridge face after loading. If colored pushers are visible, the cartridge may not contain staples. Replace with another
reload.
5. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.
6. When positioning the stapler on the application site, ensure that no unintentional obstructions, such as clips, are incorporated into
the instrument jaws. Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.
7. There is an increased risk of leak when staple lines are crossed, even if there may be clinical circumstances when a surgeon may
deem it necessary or appropriate to do so.
8. The stapler will cut and staple any tissue included in the jaws. Use caution to ensure that only tissue intended to be cut and stapled
are within the stapler jaws.
9. Failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result in
device malfunction, poor hemostasis, and/or leakage.
10. Compatibility of staple line reinforcement material with the Tri-Staple™ 2.0 radial reload has not been established.
PRECAUTIONS
1. Depending upon the stapler handle used, refer to the applicable Instructions for Use for the GIA™ universal stapler, Endo GIA™
universal staplers, Endo GIA™ Ultra universal staplers and powered stapler handles used with Endo GIA™ adapters for specific
indications, contraindications, warnings, precautions, and operating instructions.
2. The Tri-Staple™ 2.0 radial reload is not designed to fit through a standard trocar, but may be inserted through an access device
such as a hand access port or comparable access port. When using the Endo GIA™ universal handle, Endo GIA™ Ultra universal
handle or a Covidien™ powered stapler handle used with an Endo GIA™ adapter preloaded through a standard trocar, verify that
the loading graphics and unload button are fully accessible prior to attaching the radial reload. A 15 mm trocar sleeve or larger,
with the use of a converter is recommended when employing the technique of preloading the Endo GIA™ universal handle, Endo
GIA™ Ultra universal handle or Covidien™ powered stapler handle used with an Endo GIA™ adapter.
3. Tissue proximal to the tissue stops will not be stapled.
4. Tissue distal to the distal cut line on the radial reload anvil will not be cut or stapled.
5. After firing and removal of the instrument, always inspect the staple line for hemostasis and/or leakage. Minor bleeding may be
controlled by electrocautery or manual sutures. Minor leakage may be controlled by manual sutures.
6. When firing the stapler more than once during a procedure, be sure to replace the empty reload with a new one. A safety interlock
prevents the firing of an empty reload. Do not attempt to override the safety interlock; doing so will cause device malfunction.
7. Ensure that the staple reloads are compatible with the staplers.
8. Compatibility of other manufacturer’s staples and staplers has not been determined.
9. Compatibility of staple line reinforcement material with the Tri-Staple™ 2.0 radial reload has not been established.
10. This reload is provided STERILE and is intended for a single firing in a SINGLE procedure only. DISCARD AFTER USE. DO NOT
RESTERILIZE.
11. Dispose of used staplers and used reloads in accordance with the end-user’s medical and biological waste disposal requirements.
12. The titanium staples in these devices are nonferromagnetic and may undergo MRI and/or NMR procedures at 3.0 Tesla or less.
13. Always check for presence of staples in the reloads before firing.
ADVERSE REACTIONS
Possible adverse reactions and potential complications may include but are not limited to seroma/hematoma, bleeding/hemorrhage/
anastomotic leak, fistula, infection which may include intra-abdominal abscesses/sepsis, ischemia, chronic pain, allergic reactions,
inflammatory reaction, visceral adhesions, nerve entrapment, tissue erosion and small bowel perforation, potential for stricture,
potential for delayed gastric emptying, and need for future reoperation.
SCHEMATIC VIEW
A) Tri-Staple™ 2.0 RADIAL RELOAD
B) TISSUE STOP
C) ANVIL
D DISTAL CUT LINE
E) TISSUE RETAINER
F) STAPLE CARTRIDGE
G) LOAD LOCK
H) INTELLIGENCE CHIP
NOTE: For complete stapler instructions, always refer to the package insert included with the compatible
staplers for specific instructions, INDICATIONS, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS.
NOTE: For environmental conditions of use with the SigniaTM powered handle refer to the SigniaTM
powered handle package insert.
INSTRUCTIONS FOR USE
LOADING
WARNING: Always select a reload with the appropriate staple size for the tissue thickness. Overly
thick or thin tissue may result in unacceptable staple formation.
1. The reloads are packaged in the open position.
NOTE: Do not remove the load lock until the reload is loaded into the stapler handle. Remove all
extraneous packaging as required.
2. To load the Endo GIA™ radial reloads on the stapler handle, insert the pin located at the distal end of the stapler shaft
into the reload. Ensure that the LOAD alignment indicator on the reload aligns with the LOAD alignment indicator on
the stapler shaft. Push the reload in and twist clockwise 45° relative to the stapler; when the reload is locked in place,
an audible click will be heard.
NOTE: Remove the load lock prior to clamping stapler. The radial reload jaws will not close with
the load lock in place. A locking mechanism prevents removal of the load lock until the reload is
properly loaded.
3. Remove the load lock by firmly grasping and pulling it from the shaft of the reload.
WARNING: Inspect the cartridge face after loading. If colored pushers are visible, the cartridge may
not contain staples. Replace with another reload.
4. Depending upon the stapler handle used, refer to the applicable Instructions for Use for the compatible staplers for
specific indications, contraindications, warnings, precautions, and operating instructions.
STAPLE SPECIFICATIONS
I) CARTRIDGE COLOR
J) STAPLE SIZES
K) FORMED STAPLE (TYPICAL)
C
B
A
en: Staple rows, staggered staple pattern
A
B
C
en: Open
54.9 kPa
-20.2°F
-29°C
63°F
17°C
Tissue
85%
140°F
60°C
94°F
34°C
101.3 kPa
en: Intended compressed tissue thickness
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: Transport atmospheric pressure
en: Transport humidity limitations
en: Transport temperature limitations
en: Storge temperature range
en: Type CF applied part
© 2015 Covidien.
Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
www.covidien.com
+1 800 633 8766
+1 763 514 4000
COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered
trademarks of Covidien AG. Other brands are trademarks of a Covidien company, ™* brands are trademarks of their
respective owner.
2022 - 06 / 01
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