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Medtronic
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SIGTRSB45AMT
Instructions for Use
2 pgs257.77 Kb0

Medtronic SIGTRSB45AMT Instructions for Use

Tri-Staple™ 2.0
Reinforced Reload
PT00167986
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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. 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 reinforced reload is pre-attached with a polyglycolic acid (PGA) staple line reinforcement. The reload includes a non-woven absorbable mesh prepared of polyglycolic acid and dyed with D&C Green No. 6 (not to exceed
0.12 wt%) on both the anvil and cartridge. This decreases the thickness of tissue that can be compressed by 0.3 mm. The PGA reinforcement material degrades via a combination of hydrolytic and enzymatic pathways. The PGA staple line reinforcement material has been found to be biocompatible with a history of use as bio-absorbable sutures and other implantable devices. The strength profile for the reinforcement material shows mechanical strength through the critical wound healing period of 10 to 14 days post-surgery. The residual measurable strength for the reinforcement material is at least 32% at 7 days and at least 1.4% at 14 days and the reinforcement material is bio-absorbed in 15 weeks.
The PGA staple line reinforcement material is secured to the anvil and cartridge of the Tri-Staple™ 2.0 reinforced reload with a Maxon™ synthetic absorbable anchoring suture. During firing, the Maxon™ anchoring sutures release the PGA reinforcement material from the reload to allow its placement of the PGA reinforcement material on the tissue. The Maxon™ suture remains with the reload and is discarded after use.
The Tri-Staple™ 2.0 reinforced reload places a triple-staggered row of titanium staples and two layers of absorbable reinforcement material on either side of the cut line. As the staples are deployed, the tissue and staple line reinforcement material are simultaneously divided. The size of the staples is determined by the selection of the reload. The Tri-Staple™
2.0 reinforced reload is available in articulating 45 mm and 60 mm lengths in purple and black configurations. Refer to the Instructions for Use for the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, and Signia™ platforms for articulation angles.
The purple reload has height progressive rows of 3.0 mm, 3.5 mm and 4.0 mm titanium staples on either side of the cut line. The black reload has height progressive rows of 4.0 mm, 4.5 mm and 5.0 mm titanium staples on either side of the cut line.
The Tri-Staple™ 2.0 reinforced reload is provided STERILE for single use only. The Tri-Staple™ 2.0 reinforced reload is sterilized by ethylene oxide gas. The product should be stored at room temperature.
The Tri-Staple™ 2.0 reinforced reload will contain an intelligence chip. The intelligence chip will have the ability to communicate with Covidien™ powered stapling handles that have a compatible communications interface.
STAPLER HANDLE COMPATIBILITY
The Tri-Staple™ 2.0 reinforced reload can be used with the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, and Signia™ platforms. Some features of Signia™ 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 GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings, precautions, and operating instructions.
INDICATIONS
Tri-Staple™ 2.0 reinforced reloads preloaded with polyglycolic acid staple line reinforcement has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. 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 for the patch reconstruction of cardiovascular defects such as cardiac, great vessel and peripheral vascular arteries or vein.
2. To allow for the reinforcement material total thickness of 0.3 mm on a reload, the tissue thickness ranges are as follows:
For the purple reload: Do not use on tissue that does not comfortably compress to 1.2 mm-1.95 mm.
For the black reload: Do not use on tissue that does not comfortably compress to 1.95 mm-2.7 mm.
WARNINGS
1. Surgeons should consider specific patient factors before deciding if the device is suitable for use.
2. Avoid use of the instrument on the aorta.
3. 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.
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4. 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.
5. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.
6. Ensure that the staple reloads are compatible with the staplers.
8. 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.
9. 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.
10. Do not use the Tri-Staple™ 2.0 reinforced reload in conjunction with other reinforcement materials. This may cause staple malfunction and poor hemostasis resulting in leaks and tissue ischemia.
11. In the event there is extra material with or without staples protruding beyond the tissue and cut edge, remove this material with scissors.
12. Do not attempt to remove the yellow shipping wedge until the Tri-Staple™ 2.0 reinforced reload is loaded into the instrument. Failure to do so may result in loading unit jaws not opening after clamping and firing on tissue. The shipping wedge should be retained until the completion of the case. Please refer to the applicable the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms’ Instructions for Use for detailed loading instructions.
13. Do not clamp instrument prior to removing shipping wedge.
PRECAUTIONS
1. If the Tri-Staple™ 2.0 reinforced reload is inserted percutaneously, ensure the incision is wide enough to accommodate the instrument so that excessive force is not placed on the jaws of the instrument.
2. When using the Endo GIA™ Ultra universal stapler to grasp or manipulate tissue multiple times, the staple line reinforcement material secured on the anvil and cartridge may move and/or dislodge.
3. In the event that the reinforcement material shifts upon clamping, unclamp the stapler and reposition on tissue.
4. When using the Tri-Staple™ 2.0 reinforced reload with a Covidien™ powered stapler handle with Endo GIA™ adapter in challenging applications, the firing sequence may stop prematurely. The propensity to stop prematurely may increase if the reload is in the articulated position. If the firing does stop prematurely, release the blue CLOSE/FIRE button, assess the tissue for obstructions, and wait approximately 15-30 seconds to allow the tissue to compress. After waiting 15-30 seconds, press the CLOSE/FIRE button to continue the firing stroke. The knife blade will stop automatically at the distal end of the reload when the firing stroke is complete. A complete firing stroke can be confirmed by visual indicators on the powered stapler handle and the reload. In the event that the firing cannot be completed, the knife blade can be retracted and the jaws opened by pressing the silver OPEN button. Refer to Precaution #5 for instructions to release the distal Maxon™ anchoring sutures in the event of an incomplete firing.
5. When firing device, complete firing through full length of reload. In the event of an incomplete firing of the Tri-Staple™ 2.0 reinforced reload, the distal Maxon™ anchoring sutures used to secure the staple line reinforcement material to the anvil and cartridge may not be released, the inability to release the distal anchor suture will prevent the jaws from opening fully when the device is unclamped. The remaining intact staple line reinforcement material on the reload will need to be removed from the device by gentle traction and/or by cutting the anchor suture with scissors.
6. After complete firing, inspect the staple line for hemostasis; minor bleeding may be controlled by electrocautery or manual sutures. Minor leakage may be controlled by manual sutures. Additionally, small pieces of the Maxon™ sutures that secured the Tri-Staple™ 2.0 reinforced reload with the PGA staple line reinforcement material may be dislodged and observed in the surgical field.
7. Securing the target tissue prior to and during firing with an atraumatic grasper may reduce tissue slipping during the firing stroke. When closing the Tri-Staple™ 2.0 reinforced reload, the tissue may extrude distally and laterally as you clamp and/or fire when in thick tissue and/or crossing intersecting staple lines. To minimize this, the use of an atraumatic grasper is recommended to place and secure the tissue within the jaws. As the instrument is fired, use gentle proximal traction with the grasper placed next to the reload until the deployed staples provide acceptable support.
8. As with any temporary implanted prosthetic, the material can elicit a slight acute inflammatory response in tissues, and its implantation may result in inflammation or partial extrusion of material with late absorption or mechanical irritation and may result in a pH decrease by accumulation of dissolved unmetabolized degradents and inflammation caused from the pH decrease.
9. As with any foreign body, prolonged contact of this or any other reinforcement material with salt solutions, such as those found in the urinary or biliary tracts, may result in calculus formation.
10. To avoid damage or contamination, always use clean gloves and ensure care is taken when handling the Tri-Staple™ 2.0 reinforced reload, so as not to damage the staple line reinforcement material.
11. Dispose of used instruments and used reloads in accordance with the end-user’s medical and biological waste disposal requirements.
12. Store at room temperature.
13. If the desiccant packaged in the foil pouch has been compromised, discard the Tri-Staple™ 2.0 reinforced reload.
14. Before attempting to load a previously loaded but unused reload, reattach the shipping wedge ensuring that the raised post on the shipping wedge is properly seated in the anvil of the reload. Then follow the loading procedure as described in the Instructions for Use for the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms.
15. The compatibility of other manufacturers’ 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 may include but are not limited to bleeding/hematoma/ hemorrhage that may lead to death, anastomotic leak, ischemia, pneumothorax, fistula, infection that may lead to death, chronic pain, allergic reactions, calculus formation, inflammatory reaction, adhesions, tissue erosion, obstruction, perforation, unintended radiation exposure, potential for staple migration and need for future reoperation.
SCHEMATIC VIEW
A) SINGLE USE Tri-Staple™ 2.0 reinforced reload (45 or 60 mm lengths)
B) ANVIL
C) STAPLE CARTRIDGE
D) SHIPPING WEDGE
E) INTELLIGENCE CHIP
F) STAPLE LINE REINFORCEMENT
NOTE: For complete stapler instructions, always refer to the package insert included with the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific instructions, INDICATIONS, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS.
NOTE: For environmental conditions of use with SigniaTM powered handle refer to SigniaTM powered handle package insert.
INSTRUCTIONS FOR USE 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, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings, precautions, and operating instructions.
NOTE: Dipping the reload in sterile saline prior to positioning the reload at the target tissue may help flatten the material on the cartridge.
UNLOADING
1. Dependent upon the stapler handle used, refer to the applicable Instructions for Use for the GIA™ Universal, Endo GIA™ Universal, Endo GIA™ Ultra, iDrive™, or Signia™ platforms for specific indications, contraindications, warnings, precautions, and operating instructions.
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B
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en: Staple rows, staggered staple pattern
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B
C
en: Open
Tissue
94°F 34°C
63°F 17°C
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 use if package is damaged
en: Consult instructions for use
en: Caution
en: Do not resterilize
en: MR Conditional
en: Store at room temperature
101.3 kPa
en: Transport atmospheric pressure
54.9 kPa
85%
en: Transport humidity limitation
140°F 60°C
-20.2°F
-29°C
© 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 / 02
en: Transport temperature limitations
en: Type CF Applied Part
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