Medtronic GIA80MTC Instructions for Use
GIA™
Cartridge with Tri-Staple™ Technology
PT00168177
A
GIA80MTC
GIA80XTC
GIA60MTC
GIA60XTC
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 60mm and 80mm length.
The GIA™ stapler and cartridges with Tri-Staple™ technology are available in two staple sizes to accommodate various
tissue thicknesses: medium/thick and extra thick.
Cartridges with medium/thick staple size (purple) deploy three height-progressive rows of 3.0mm, 3.5mm and 4.0mm
titanium staples. Cartridges 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 in the GIA™ stapler product insert.
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
8times per instrument. Additional applications may cause improperly formed staples which may result in leakage or
disruption of the staple line.
7. When using the instrument more than once during the same procedure, be sure that the anvil is clear of tissue, blood
and staples following each application.
8. When used in the abdomen, make sure no omentum or mesenteric vessels are caught between the cartridge and anvil
B
80 mm
80 mm
60 mm
60 mm
C
PURPLE
BLACK
PURPLE
BLACK
4 mm
5 mm
4 mm
5 mm
D
3.5 mm
4.5 mm
3.5 mm
4.5 mm
3 mm
4 mm
3 mm
4 mm
E F
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
assembly prior to locking the instrument.
9. The GIA™ stapler with Tri-Staple™ technology is provided STERILE and are 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.
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 lifethreatening 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 and black). 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 and cartridges 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.
SPECIFICATION CHART
A) CARTRIDGE REORDER CODES
B) STAPLE LINE LENGTH
C) CARTRIDGE COLOR
D) OPEN STAPLE SIZE
E) CLOSED STAPLE SIZE
F) TISSUE COMPRESSION REQUIREMENT
Refer to the instrument package insert for specific use instructions.
Please reference the instrument package insert for specific information on staple dimensions, closure, and
tissue compression requirements.
STORE AT ROOM TEMPERATURE.
C
B
A
en: Staple rows, staggered staple pattern
A
B
C
en: Open
Tissue
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: Caution
en: MR Conditional
en: Package quantity
en: CE mark
0123
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2022 - 07 / 01
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