Tri‑Staple™ 2.0
Reloads and Curved Tip Reloads
PT00167981
A
M
mm
mm
mm
mm
mm
mm
mm
mm
mm
mm
2
2
3
2
2
3
4
2
3
4
C
T
.75 - 1 mm
.88 - 1.8 mm
1.5 - 2.25 mm
.75 - 1 mm
.88 - 1.8 mm
1.5 - 2.25 mm
2.25 - 3.0 mm
.88 - 1.8 mm
1.5 - 2.25 mm
2.25 - 3.0 mm
B
E
D
F
G
I
H
J
K
L
N
B
O
P
4
5
Q R S
30 mm
Gray
30 mm
30 mm
Purple
45 mm Gray
45 mm
45 mm
Purple
45 mm
Black
60 mm
60 mm
Purple
60 mm
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.
This device was designed, tested and manufactured for single patient use only. Reuse or reprocessing of this device may
lead to its failure, subsequent patient injury, or death. 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 Tri‑Staple™ 2.0 reloads and Tri‑Staple™ 2.0 curved tip reloads 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 reload:
The Tri‑Staple™ 2.0 reload is available in articulating 30 mm, 45 mm and 60 mm length, the Tri‑Staple™ 2.0 curved tip
reload is available in articulating 30 mm, 45 mm and 60 mm lengths and the Tri‑Staple™ 2.0 black reload is available in
articulating 45 mm and 60 mm lengths.
Tri‑Staple™ 2.0 Extra Thin/Vascular Reloads:
Gray 30 mm reload, gray 30 mm curved tip reload and gray 45 mm curved tip reload – three rows of 2.0 mm titanium
staples on either side of the cut line.
Tri‑Staple™ 2.0 Vascular/ Medium Reloads:
Tan 30 mm reload, tan 30 mm curved tip reload, tan 45 mm curved tip reload and tan 60 mm curved tip reload ‑ 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 Reloads:
Purple 30 mm reload, purple 45 mm curved tip reload and purple 60 mm curved tip reload ‑ three height progressive rows
of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the cut line.
Tri‑Staple™ 2.0 Extra Thick Reload:
Black 45 mm reload and black 60 mm reload ‑ three height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium
staples on either side of the cut line.
The curved tip on the distal‑end of the curved tip reload can be used to dissect and manipulate tissue/vessels when
locating target tissue for subsequent firing and placement of staples. The flexible introducer provided with the curved tip
reload can be mounted on the curved tip and used to guide the anvil underneath the vessel/tissue that is to be transected.
2
mm2mm
3
mm
4
mm
2
mm2mm
3
mm
4
mm
5
mm
3
mm
4
mm
5
mm
2.5
mm
3.5
mm
2.5
mm
3.5
mm
4.5
mm
2.5
mm
3.5
mm
4.5
mm
Tan
Tan
Tan
STAPLER HANDLE COMPATIBILITY
The Tri‑Staple™ 2.0 reloads can be used with Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, and Signia™ platforms.
Some features of the Signia™ platform are only compatible with single use reloads with Tri‑Staple™ 2.0 reloads, Signia™
intelligent loading units.
Refer to the Instructions for Use for the Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, and Signia™ platforms for specific
indications, contraindications, warnings, precautions, and operating instructions.
Refer to the Instructions for Use for the Endo GIA™ Universal, Endo GIA™ Ultra, 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 Tri‑Staple™2.0 single use purple
and black reloads.
Compatibility of other manufacturer’s staples and staplers has not been determined.
INDICATIONS
The Tri‑Staple™ 2.0 reloads have applications in abdominal, gynecologic, 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 Tri‑Staple™ 2.0 curved tip reloads can be used to blunt dissect or separate target tissue from other tissue.
CONTRAINDICATIONS
1. Do not use the Tri‑Staple™ 2.0 reload or Tri‑Staple™ 2.0 curved tip reload extra thin/vascular (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 reload or Tri‑Staple™ 2.0 curved tip reload vascular/ medium (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.
3. Do not use the Tri‑Staple™ 2.0 reload or Tri‑Staple™ 2.0 curved tip 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.
4. Do not use the Tri‑Staple™ 2.0 black extra thick reload 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.
5. The Tri‑Staple™ 2.0 reload instruments should not be used on friable or delicate tissue and/or 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. The use of curved tip reloads is contraindicated on tissue or structures that cannot fit completely within the jaws proximal
to the transitional angle of the curved tip.
9. These devices are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. DO NOT
RESTERILIZE.
WARNINGS
1. Ensure that the staple reloads are compatible with the staplers.
2. 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 and Covidien™ powered stapler handles used with Endo
GIA™ adapters for specific indications, contraindications, warnings, precautions, and operating instructions.
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 reload 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 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. 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.
9. 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.
10. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.
11. When dividing major vascular structures, be sure to adhere to the basic surgical principles of proximal and distal control.
12. When manipulating tissue with the curved tip reloads, avoid exerting excessive pressure on fragile structures with the
curved tip of the device.
13. 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.
14. Failure to completely fire the reload will result in an incomplete cut and/or incomplete staple formation, which may result
in poor hemostasis and/or leakage.
15. Tri‑Staple™ 2.0 reloads 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 and Covidien™ powered stapler handles used with Endo
GIA™ adapters for specific indications, contraindications, warnings, precautions, and operating instructions.
2. When inserting the Tri‑Staple™ 2.0 black reload into a trocar, the instrument MUST be inserted into a 15mm trocar. A
smaller size trocar will not accept the Tri‑Staple™ 2.0 black reload.
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 reinforced reload to grasp or manipulate target tissue multiple
times, the reinforcement material may move and/or dislodge.
7. Do not attempt to remove the shipping wedge until the reload is loaded into the instrument. Failure to do so may result
in reload jaws not opening after clamping and firing on tissue. This may cause the inability to fire the device which can
delay treatment and potentially cause tissue damage. The shipping wedge should be retained until the completion of
the case.
8. Do not clamp instrument prior to removing shipping wedge.
9. The jaws of the reload must be closed prior to introducing the instrument into the trocar sleeve or the incision. To do
so, squeeze the handle. Do not attempt to insert or remove the instrument from the incision, or trocar sleeve if the
instrument is in the articulated position.
10. 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.
11. 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.
12. The Tri‑Staple™ 2.0 reloads and curved tip reloads are single use. A safety interlock is provided that prevents an empty
single use reload from being fired a second time. Do not attempt to override the safety interlock. Overriding the safety
interlock will cause device malfunction.
13. The instrument will not cut tissue beyond the black cut line indicated on the single use reload. More than one application
of the stapler may be necessary for tissue exceeding the length of the reload (30 mm, 45 mm or 60 mm).
14. 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.
15. The anvil must be completely visible, (past the trocar sleeve) prior to opening the reload within the body cavity.
16. In case of a curved tip reload, ensure that the tissue/vessel to be transected does not extend beyond the black cut line
on the reload. The device will only cut to the black cut line. Tissue contained within the jaws distal to this line will not
be transected.
17. The curved tip reload cannot be used for blunt dissection with the introducer attached.
18. Do not apply excessive force to the introducer, excessive force may separate it from the anvil.
19. Dispose of used instruments and used reloads in accordance with the end‑user’s medical and biological waste disposal
requirements.
20. The device may become locked on tissue and may result in tissue trauma and/or unanticipated tissue loss.
21. Compatibility of other manufacturer’s staples and staplers has not been determined.
MRI SAFETY 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 MRI 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 2 mm 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 include: seroma/hematoma, bleeding/hemorrhage/leak, ischemia,
chronic pain, infection, allergic reactions, inflammatory reaction, visceral adhesions, fistula, nerve entrapment, tissue
erosion, small bowel perforation, and need for future operation.
SCHEMATIC VIEW
A) SINGLE USE RELOAD (30, 45, or 60 mm lengths)
B) SHIPPING WEDGE
C) INTELLIGENCE CHIP
D) ANVIL
E) TISSUE STOP
F) END OF CUT LINE
G) END OF STAPLE LINE
H) LOWER CLAMP COVER
I) INCREMENT MARKINGS
J) STAPLE CARTRIDGE
K) SINGLE USE CURVED TIP RELOAD (30, 45, 60)
L) FLEXIBLE INTRODUCER
M) FLEXIBLE INTRODUCER MOUNTING CLIP
N) SINGLE USE RELOAD (shipping wedge attachment)
O) SHIPPING WEDGE POST
P) ANVIL LOCATING HOLE
NOTE: For environmental conditions of use with Signia™ powered handle refer to Signia™ powered
handle package insert.
LOADING
1. The reload is packaged in the open position. Do not attempt to close the reload.
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.
CAUTION: Do not attempt to remove the shipping wedge until the reload is loaded into the
instrument. The shipping wedge should be retained until the completion of the case.
CAUTION: Do not clamp instrument prior to removing shipping wedge.
2. 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 Covidien™ powered stapler handles used with
Endo GIA™ adapters for specific indications, contraindications, warnings, precautions, and operating instructions.
UNLOADING
Dependent 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 Covidien™ powered stapler handles used with Endo GIA™
adapters for specific indications, contraindications, warnings, precautions, and operating instructions.
INSTRUCTIONS FOR USE
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 Covidien™ powered stapler handles used with
Endo GIA™ adapters for specific indications, contraindications, warnings, precautions, and operating instructions.
2. In case of the curved tip reload, the curved tip of the anvil can be used to manipulate the tissue and will be clearly
visible when the reload is clamped on the tissue/vessel that has to be transected.
WARNING: When manipulating tissue with the curved tip reloads, avoid exerting excessive pressure
on fragile structures with the curved tip of the device.
CAUTION: In case of a curved tip reload, ensure that the tissue/vessel to be transected does not
extend beyond the black cut line on the reload. The device will only cut to the black cut line. Tissue
contained within the jaws distal to this line will not be transected.
3. The curved tip reload can be used with or without the flexible introducer provided with the reload. Surgeons may
mount the introducer on the curved tip and use it to guide the anvil into position and underneath the vessel/tissue
that is to be transected.
4. The introducer is mounted to the curved tip by pushing the mounting clip end of the introducer onto the curved tip
of the anvil.
CAUTION: The curved tip reload cannot be used for blunt dissection with the introducer attached.
5. Pass the introducer behind the structure to be stapled; an appropriately sized right angled clamp may be used to assist
passing the introducer.
CAUTION: Do not apply excessive force to the introducer, excessive force may separate it from the
anvil.
NOTE: The introducer and its mounting clip are radioopaque in the event that either inadvertently
detaches from the curved tip reload.
6. Use the introducer to guide the anvil behind the structure to be stapled.
WARNING: 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.
7. The instrument may be fired with the introducer in place; or the introducer may be removed prior to firing.
STAPLE SPECIFICATIONS
Q) STAPLE LINE LENGTH
R) COLOR
S) OPEN STAPLE SIZE
T) INTENDED TISSUE THICKNESS RANGE
54.9 kPa
A
‑20.2°F
‑29°C
63°F
17°C
B
A
C
B
Tissue
85%
C
140°F
60°C
94°F
34°C
101.3 kPa
en: Staple rows, staggered staple pattern
en: Open
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: MR Conditional
en: Transport atmospheric pressure
en: Transport humidity limitations
en: Transport temperature limitations
en: Storge temperature range
en: Type CF applied part
en: Package quantity
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2022 ‑ 07 / 03
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