Medtronic GIA80XTS Instructions for Use
7. When using the instrument more than once during the same procedure, be sure that the anvil is clear of tissue, blood
3
G
H
I
J
A
C
B
D
E
F
B
1
2
G
2
G
H
1
4
1
E
5
E
and staples following each application.
GIA™
K
Stapler with Tri-Staple™ Technology
PT00168176
A
F
1
1
C
B
D
E
B
G
H
I
J
2
GIA80MTS
GIA80XTS
GIA60MTS
G
GIA60XTS
M
L
GIA80MTC
GIA80XTC
GIA80MTC
GIA80XTC
GIA60MTC
GIA60XTC
GIA60MTC PURPLE
GIA60XTC
N
80
PURPLE
mm
80
BLACK
mm
80
PURPLE
mm
80
BLACK
mm
60
PURPLE
mm
60
BLACK
mm
60
mm
60
BLACK
mm
O P Q
3.5 mm
4.5 mm
3.5 mm
4.5 mm
3.5 mm
4.5 mm
3.5 mm
4.5 mm
3 mm
4 mm
3 mm
4 mm
3 mm
4 mm
3 mm
4 mm
4 mm
5 mm
4 mm
5 mm
4 mm
5 mm
4 mm
5 mm
1.2 - 1.75
mm
1.7 - 2.25
mm
1.2 - 1.75
mm
1.7 - 2.25
mm
1.2 - 1.75
mm
1.7 - 2.25
mm
1.2 - 1.75
mm
1.7 - 2.25
mm
1.5 - 2.25
mm
2.25 - 3.0
mm
1.5 - 2.25
mm
2.25 - 3.0
mm
1.5 - 2.25
mm
2.25 - 3.0
mm
1.5 - 2.25
mm
2.25 - 3.0
mm
3
4
1
H
E
E
5
2
G
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. 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 GIA™ stapler with Tri-Staple™ technology places two triple staggered rows of titanium staples and simultaneously cuts and
divides tissue between these two triple rows. The GIA™ stapler and cartridges with Tri-Staple™ technology are currently available in
60 mm and 80 mm length.
The GIA™ stapler with Tri-Staple™ technology is currently available in two staple sizes to accommodate various tissue thicknesses:
medium/thick and extra thick.
Staplers with medium/thick staple size (purple) deploy three height-progressive rows of 3.0mm, 3.5mm and 4.0mm titanium
staples. Staplers with extra thick staple size (black) deploy three height progressive rows of 4.0mm, 4.5mm and 5.0mm titanium
staples. Please refer to the “SPECIFICATION CHART” for availability of staple sizes and cartridge lengths.
Each GIA™ stapler with Tri-Staple™ technology may be reloaded up to 7 times for a total of 8 firings per instrument.
INDICATIONS
The GIA™ stapler with Tri-Staple™ technology has applications in abdominal and thoracic surgical procedures for resection, transection
and creation of anastomosis.
CONTRAINDICATIONS
1. The instrument should not be used on tissue such as liver or spleen where compressibility is such that closure of the instrument
would be destructive.
2. The instrument should not be used to staple tissues that are necrotic, friable, or have altered integrity, e.g., ischemic or edematous
tissues.
3. Tissue thickness should be carefully evaluated before firing any stapler. Refer to “SPECIFICATION CHART” and the “Tissue
Compression Requirements” section.
4. “Tissue Compression Requirement” refers to the tissue compression requirement for each staple size. If the tissue cannot
comfortably compress to the specified minimum requirement, or compresses to less than this requirement, the tissue may be too
thick or too thin for the selected staple size.
5. Do not use this device for vascular resection and transection. .
WARNINGS AND PRECAUTIONS
1. 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.
2. Avoid use of the instrument on the aorta.
3. Visually inspect prior to firing for inclusion of unintended anatomic structures within the staple line.
4. When positioning the stapler on the application site, ensure that no unintentional obstructions, such as clips, are incorporated
between the anvil and the cartridge prior to clamping. Firing over an obstruction may result in incomplete cutting action and/or
improperly formed staples.
5. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.
6. The GIA™ stapler with Tri-Staple™ technology is designed to be fully disposable and should not be fired more than 8 times per
instrument. Additional applications may cause improperly formed staples resulting in leakage or disruption of the staple line.
8. When used in the abdomen, make sure no omentum or mesenteric vessels are caught between the cartridge and anvil
assembly prior to locking the instrument.
9. The GIA™ stapler with Tri-Staple™ technology is provided STERILE and is intended for multiple use during a SINGLE
procedure. DISCARD AFTER USE. Reuse, reprocessing and/or resterilization of this device may create the risk of
contamination, patient infection, permanent impairment or life-threatening injury. Do not reuse, reprocess or resterilize
this device.
10. The cartridges are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. Reuse,
reprocessing and/or resterilization of this device may create the risk of contamination, patient infection, permanent
impairment or life-threatening injury. Do not reuse, reprocess or resterilize this device.
11. Ensure that the staples are compatible with the stapler. The GIA™ cartridges with Tri-Staple™ technology can only be
used with the GIA™ staplers with Tri-Staple™ technology. Compatibility of other manufacturer’s staples and staplers
has not been determined.
12. Compatibility of other manufacturer’s staple line reinforcement material for use with GIA™ cartridges with Tri-Staple™
technology has not been determined.
13. The instrument should not be used to staple tissue outside of the labeled limits for maximum and minimum tissue
thickness.
14. Ensure to select a cartridge with the appropriate staple size for the tissue thickness. Overly thick or thin tissue may result
in unacceptable staple formation.
15. All GIA™ staplers with Tri-Staple™ technology of the same length can be used for both color cartridges (purple
medium/thick cartridge and black extra thick cartridge). There is no need to change the stapler if you are only replacing
one color cartridge with another and not changing the length of cartridge.
16. After firing, always inspect the staple line for hemostasis.
17. Failure to advance the handle completely may result in incomplete staple formation, which may compromise the
integrity of the staple line.
18. Do not rotate the firing knob during firing. Rotating the knob during firing may cause damage and possible instrument
malfunction.
19. Dispose of the used instrument in accordance with the end-user’s medical and biological waste disposal requirements.
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 2mm from the titanium staple when
imaged with a gradient echo pulse sequence and a 3.0T MRI system.
ADVERSE EVENTS
Adverse reaction and potential complications associated with the use of the GIA™ stapler with Tri-Staple™ technology are:
anastomotic leak, infection that may lead to death, organ perforation, inammation, pneumothorax when used for thoracic
indication, bleeding that may lead to death, pain, stula, tissue damage, obstruction, nerve entrapment, ischemia, allergic
reaction and stenosis/stricture.
SCHEMATIC VIEW
A) CARTRIDGE FORK
B) SHOULDER
C) LOCKING LEVER HANDLE
D) RELEASE BUTTON
E) FIRING KNOB
F) ANVIL FORK
G) SHIPPING WEDGE ( Top View)
H) CARTRIDGE
I) KNIFE BLADE ASSEMBLY
J) SAFETY LOCKOUT
INSTRUCTIONS FOR USE
FIRING INSTRUCTIONS
CAUTION: Ensure to select a cartridge with the appropriate staple size for the tissue thickness.
Overly thick or thin tissue may result in unacceptable staple formation.
1. Open the instrument by pushing in on the release button on the cartridge fork lever handle (located at end of instrument).
2. Remove the shipping wedge (G) from cartridge channel by lifting and pulling it out at the finger tabs. (Remove
shipping wedge after cartridge is fully loaded. Cartridge will “float” up and down in final loaded position.)
3. Position the tissue to be stapled between the instrument cartridge and anvil fork; or, if the tissue is to be anastomosed,
place the cartridge fork in one lumen and the anvil fork into the other lumen as appropriate. Align tissue edges equally
on cartridge and anvil. This may be accomplished with the instrument halves separated or hinged at the rear. Close the
instrument by moving the lever handle towards the instrument body until the audible click is heard.
NOTE: Pre-compression of tissues during use of the GIA™ stapler with Tri-Staple™ technology is
recommended prior to stapler firing.
4. With the instrument securely closed, rotate the firing knob (E) to either side of the instrument.
NOTE: In its pre-fire position, the firing knob should rotate to either side of the instrument.
5. Place a thumb behind the firing knob and two fingers on the instrument shoulders. Fire the instrument by sliding the
firing knob (E) forward to a complete stop.
CAUTION: Failure to advance the firing knob fully during firing may result in unacceptable staple
formation and/or an incomplete knife cut. An unacceptable staple formation may result in leakage.
Ensure that the firing knob is always fully advanced to a complete stop.
CAUTION: Do not rotate the firing knob during firing. Rotating the knob during firing may cause
damage and possible instrument malfunction.
6. After firing, return firing knob all the way back to its pre-fire position.
7. Push in the cartridge release button to open the instrument (refer to step 1). Remove the instrument from the surgical
site.
CAUTION: 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.
CAUTION: After firing, always inspect the staple line for hemostasis.
NOTE: When a fired instrument is opened, the lockout device will deploy. The safety lockout
prevents clamping of the instrument with a cartridge that has been fired.
RELOADING INSTRUCTIONS
1. To remove the fired cartridge (H), separate the instrument halves. Holding the cartridge half of the instrument, grasp
the proximal end of the cartridge tabs and pull up and out to remove cartridge from instrument.
2. To place a new cartridge into the instrument, hold the cartridge by the proximal end tabs and insert into the cartridge
fork at a 30 to 45 degree angle from the distal end down until unit snaps into place. Remove shipping wedge (G) after
cartridge is fully loaded. cartridge will “float” up and down in final loaded position.
CAUTION: Ensure to select a cartridge with the appropriate staple size for the tissue thickness.
Overly thick or thin tissue may result in unacceptable staple formation.
NOTE: When the cartridge is upsized or downsized for its staple height only (upsized from purple to
black or downsized from black to purple) keeping its length the same, we can continue to use the
same stapler.
CAUTION: When the stapler is upsized or downsized based on the length of the stapler, ensure that
the stapler length and cartridge length always match.
CAUTION: The GIA™ stapler with Tri-Staple™ technology should only be reloaded seven (7) times per
instrument for a total of eight (8) firings.
SPECIFICATION CHART
K) STAPLER REORDER CODES
L) CARTRIDGE REORDER CODES
M) STAPLE LINE LENGTH
N) CARTRIDGE COLOR
O) OPEN STAPLE SIZE
P) CLOSED STAPLE SIZE
Q) TISSUE COMPRESSION REQUIREMENT
STORE AT ROOM TEMPERATURE.
C
B
A
en: Staple rows, staggered staple pattern
A
B
C
en: Open
Tissue
7
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: Caution
en: MR Conditional
en: Package quantity
en: CE mark
0123
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