GIA™ Auto Suture™
Loading Unit with DST Series™ Technology
PT00167848
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, patient infection, permanent impairment or life threatening injury. Do not reuse, reprocess or resterilize
this device.
DESCRIPTION
The GIA™ 60, 80 and 100 staplers place two double staggered rows of titanium staples and simultaneously cut and divide
tissue between the two double rows. The staplers and single use loading units (SULU) are available in 60 mm, 80 mm,
and 100 mm lengths.
The staplers and SULUs are available in three staple sizes to accommodate various tissue thicknesses: 2.5 mm, 3.8 mm
and 4.8 mm.
Please refer to the “SPECIFICATION CHART” in the GIA™ stapler product insert for availability of staple sizes and cartridge
lengths.
Each stapler may be reloaded up to 7 times for a total of 8 firings per instrument. For reloading instructions, see the
instrument’s Instructions for Use.
INDICATIONS
The GIA™ reloadable staplers have 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 on 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.
WARNINGS AND PRECAUTIONS
1. The instrument should not be used to staple tissue outside of the intended compressed tissue thickness.
2. Avoid use of the instrument on the aorta.
3. 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.
4. The GIA ™ 60, 80 and 100 staplers are designed to be fully disposable and should not be fired more than 8 times per
instrument. Additional applications may cause improperly formed staples which may result in leakage or disruption
of the staple line.
5. 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.
6. 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. Prior to firing, ensure that no unintentional obstructions, such as clips, are incorporated into the instrument jaws when
positioning the stapler on the application site, and that firing over an obstruction may result in incomplete cutting
action and/or improperly formed staples.
8. 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.
9. Where practical, proximal control of blood vessels is recommended prior to stapling. Methods of blood vessel control
should be in place in the event of stapler failure. When dividing major vascular structures, be sure to adhere to the basic
surgical principles of proximal and distal control.
10. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.
11. When used in the abdomen, make sure no omental or mesenteric vessels are caught between the cartridge and anvil
assembly prior to locking the instrument.
12. The GIA™ 60, 80 and 100 staplers are provided STERILE and are intended for multiple use during a SINGLE procedure.
DISCARD AFTER USE. 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.
13. The SULUs are provided STERILE and are intended for use in a SINGLE procedure only. DISCARD AFTER USE. 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.
14. 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 the GIA™ stapler with
DST Series™ technology.
15. If using a reinforcement product, include the thickness of the respective product into the overall tissue thickness to determine the
appropriate staple size that will be applied.
16. When using a staple line buttressing material, follow the instructions provided by the manufacturer of the buttress material, as
performance of the stapler may be affected when using buttress materials.
17. Ensure that the staple reloads are compatible with the staplers. The compatibility of other manufacturers’ staples and staplers has
not been determined.
18. Ensure to select a SULU with the appropriate staple size for the tissue thickness. Overly thick or thin tissue may result in
unacceptable staple formation.
19. After firing, always inspect the staple line for hemostasis. Minor bleeding may be controlled by electrocautery or manual sutures.
Minor leakage may be controlled by manual sutures. At the surgeon’s discretion, a laparotomy or thoracotomy may be performed.
20. Failure to advance the handle completely may result in incomplete staple formation, which may compromise the integrity of the
staple line.
21. Do not rotate the firing knob during firing. Rotating the knob during firing may cause damage and possible instrument
malfunction.
22. Dispose of used instruments and used reloads 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 2 mm from the titanium staple when imaged
with a gradient echo pulse sequence and a 3.0T MRI system.
ADVERSE REACTIONS
Adverse reaction and potential complications associated with the use of the GIA™ staplers and loading units are: anastomotic leak,
infection, bleeding, tissue damage, organ perforation, fistula, adhesions, stenosis/stricture, staple migration and allergic reaction.
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.
en: Open
en: Staple rows, staggered staple pattern
Tissue
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Covidien llc, 15 Hampshire Street, Mansfield, MA 02048 USA.
www.covidien.com
+1 800 633 8766
+1 763 514 4000
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trademarks of Covidien AG. Other brands are trademarks of a Covidien company, ™* brands are trademarks of their
respective owner.
2022 - 06 / 03
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 consult accompanying documents
en: MR Conditional
en: High density
en: Made from 100% recycled fibres.Minimum 35% post-consumer content.
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