Medtronic TA4535L Instructions for Use
TA™
Loading Unit with DST Series™ Technology
PT00167878
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D
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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 and 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 TA™ loading units with DST Series™ technology are intended to reload the TA™ Stapler with DST Series™ technology.
They place a double staggered row of titanium staples which are available in 30 mm, 45 mm, 60 mm and 90 mm staple
line lengths for use in various applications. The TA™ 30-V3 single use loading unit places a triple staggered row of titanium
staples. Three staple sizes (2.5 mm, 3.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses.
INDICATIONS
The TA™ loading unit with DST Series™ technology has applications in abdominal, gynecological, pediatric and thoracic
surgical procedures for resection or transection of tissue.
WARNINGS AND PRECAUTIONS
1. Ensure that the staple reloads are compatible with the staplers.
2. 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.
3. 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 improperly formed staples.
4. 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.
5. Clamping and unclamping of delicate structures may result in damage to tissue irrespective of stapler firing.
6. Do not use stapler on major vessels without making provisions for proximal and distal control.
7. Visually inspect prior to firing for inclusion of unintended anatomic structures within the staple line.
8. Avoid use of the device on the aorta.
9. The device should not be used to staple tissue outside of the labeled limits for tissue thickness.
10. Each component in the package must be used in the manner indicated.
11. The TA™ staplers with DST Series™ technology are provided STERILE and are intended for multiple use during a
single surgical 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.
12. The SULU is provided STERILE and is 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.
13. Do not modify this instrument or loading unit. Use of a modified device may result in improper instrument function.
14. Each loading unit will fit and operate properly in only the instrument(s) designed for use with the loading unit.
Attempting to use a loading unit in any instrument other than that for which it has been designed will result in stapler
malfunction.
15. Compatibility of staple line reinforcement material for use with the device has not been determined.
16. Compatibility of other manufacturer’s staples and staplers has not been determined.
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17. 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
Possible adverse reactions and potential complications are: bleeding/hematoma/hemorrhage that may lead to death, anastomotic
leak, fistula and infection which includes intraabdominal abscesses, peritonitis, sepsis that may lead to death, ischemia, chronic
pain, allergic reactions, inflammatory reaction, visceral adhesions, small bowel obstruction, perforation, stenosis, potential for staple
migration and need for future re-operation.
SCHEMATIC VIEW
A) LOADING UNIT FRONT VIEW
B) LOADING UNIT SIDE VIEW
C) STAPLE LINE
D) RETAINING PIN
INSTRUCTIONS FOR USE
For use of the stapler instrument, refer to TA™ stapler package insert for specific use instructions, cautions, and contraindications.
RELOADING
1. Ensure that the instrument jaws are in the fully open position, and the alignment pin is fully retracted before removing the single
use loading unit.
2. To remove the loading unit, grasp the finger pads (E) at the top of the loading unit and pull straight up from the jaws.
Prior to reloading the instrument, any tissue and/or formed but unused staples must be cleared from the anvil surface to ensure
proper staple formation in subsequent firings.
3. To reload the instrument, grasp the new, unused loading unit by the finger pads, with the staple holes facing the instrument
anvil. Insert the loading unit into the metal cartridge housing and push firmly downward until the single use loading unit clicks
into position.
CAUTION: The instrument jaws will not close if a loading unit has not been loaded into the jaws, if the
loading unit is not fully loaded into the jaws, or if a fired, or partially fired, loading unit is in the jaw. Always
ensure the proper loading unit is being used for the tissue thickness. An empty loading unit can be identified
by the presence of yellow pushers in the front of the staple slots.
4. Repeat the loading procedure as needed.
NOTE: Each TA™ stapler should only be reloaded up to 7 times for a total of 8 firings per instrument.
Please reference the specification chart in the TA™ stapler Instructions for Use for specific information on staple dimension, closure
and available cartridges.
en: Open
en: Staggered staple rows
Tissue
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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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