EEA™ OrVil™ Auto Suture™
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Transoral Circular Stapler Anvil
Advancing Proximal Guide Suture
For use with EEA™ XL Circular Stapler with DST
Series™ Technology
PT00167952
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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. 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 EEA™ OrVil™ transoral circular stapler anvil comes with the anvil head secured in the tilted position.
The anvil assembly is mounted on a 90 cm long PVC delivery tube and is secured to the tube with a retention suture. An advancing
proximal guide suture is attached to the anvil assembly to facilitate proximal control. The advancing proximal guide suture is supplied
in a reel and can be deployed as needed. When used with the EEA™ 21 or 25 mm XL stapler, a circular, double staggered row of
titanium staples is placed. Immediately after staple formation, the stapler knife blade resects the excess tissue, creating a circular
anastomosis. The diameter of the staple line is 21 mm or 25 mm, depending on the device selected.
The EEA™ OrVil™ anvil is permanently affixed to the center rod and cannot be removed from the center rod.
COMPATIBILITY
The EEA™ OrVil™ anvil 21 mm (aqua) is compatible with the EEA™ XL stapler 21mm and the EEA™ OrVil™ anvil 25 mm (white) is
compatible with the EEA™ XL stapler 25mm.
Refer to the respective IFUs of the stapler for complete information on the use of the devices.
Compatibility of other manufacturer’s staplers has not been determined.
INDICATIONS
The EEA™ OrVil™ 21 mm transoral circular stapler anvil when used with the DST Series™ EEA™ XL 21 mm stapler, and the EEA™ OrVil™
25 mm transoral circular stapler anvil when used with the DST Series™ EEA™ XL 25 mm stapler has applications throughout the
alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries,
including bariatric surgery.
CONTRAINDICATIONS
Refer to the instructions for use for the EEA™ XL stapler for specific indications, contraindications, warnings, precautions, and operating
instructions.
WARNINGS AND PRECAUTIONS
1. Tissue thickness should be carefully evaluated before firing any stapler. Refer to the stapler specification chart and the “tissue
compression requirements” section in the EEA™ XL stapler instructions for use.
EEA™ staplers should not be used on tissue that does not meet the specified requirements.
2. The transoral circular stapler anvil is compatible with the corresponding diameter EEA™ XL stapler length products ONLY. The
EEA™ OrVil™ anvil 21 mm (aqua) is compatible with the EEA™ XL stapler 21mm and the EEA™ OrVil™ anvil 25 mm (white) is
compatible with the EEA™ XL stapler 25mm . They are not compatible with the 22 cm long products or any other EEA™ stapler.
3. Ensure that the anvil is compatible with the stapler by matching the color on the anvil center rod to the staple cartridge. Use of an
improperly matched instrument and anvil assembly combination will cause instrument malfunction and/or staple malformation.
Malformed staples may compromise the integrity of the staple line, resulting in leakage or disruption.
4. Improper cutting and removal of the anvil retaining suture could leave the suture in place, which may result in the suture being
stapled to the anastomotic site.
5. The delivery tube should be carefully inspected after removal to ensure the anvil retaining suture has been removed with the
delivery tube.
6. The anvil retaining and advancing proximal guide sutures are not intended for use as a surgical suture in this application; their only
functions are to retain and guide the anvil assembly.
7. In the event that an obstruction impedes the advancement of the delivery tube, do not apply excessive force as this may result in
tissue damage or detachment of the delivery tube from the anvil center rod.
8. Avoid use of the device on the aorta.
9. When mating the anvil with the stapler, ensure that the anvil center rod is aligned with the integrated trocar of the stapler. Do not
grasp/clamp on the legs (open end) of the anvil/center rod assembly. Doing so can bend the legs and make it difficult to attach/
detach the anvil to the integrated trocar of the stapler. When attaching the anvil to the instrument, hold the black twist knob on
the handle of the instrument firmly to prevent the integrated trocar from moving back slightly into the head of the device. This is
especially important when using an EEA™ OrVil™ device.
10. The use of a shortened delivery tube with the white accessory fitting (in procedures other than transoral) is at the discretion of
the surgeon.
11. A shortened delivery tube is not for use in transoral applications.
12. This device and included accessories are provided STERILE and are intended for a single firing in a SINGLE procedure only. DISCARD
AFTER USE. DO NOT RESTERILIZE.
13. Dispose of used devices in accordance with the end-user’s medical and biological waste disposal requirements.
14. Failure to control the advancing proximal guide suture may result in the suture being stapled to the anastomotic site.
15. The anvil head and suture reel should be inspected after removal to ensure the advancing proximal guide suture has been removed
with the suture reel.
16. In the event that the proximal guide suture does not release after firing the instrument, remove the stapler from the anastomotic
site as outlined in the instructions for the EEA™ XL stapler and cut one side of the proximal guide suture as close to the anvil as
possible. Once this is done, remove the proximal guide suture as described in the instructions for use Step 10 below.
SCHEMATIC VIEW
A) DELIVERY TUBE
B) CENTER ROD
C) AQUA (21 mm) or WHITE (25 mm) PLASTIC COLLAR
D) ANVIL RETAINING SUTURE (NON-ABSORBABLE, BRAIDED POLYESTER)
E) Tilt-Top™ PLUS ANVIL HEAD (TILTED)
F) Tilt-Top™ ANVIL/CENTER ROD ASSEMBLY
G) ANVIL ASSEMBLY LEGS
H) Tilt-Top™ PLUS ANVIL HEAD (OPEN)
I) BULB TIP
J) WHITE ACCESSORY FITTING
K) ADVANCING PROXIMAL GUIDE SUTURE (NON-ABSORBABLE, BRAIDED POLYESTER)
L) REEL
INSTRUCTIONS FOR USE
WARNING: The EEA™ OrVil™ anvil 21 mm and 25 mm devices are compatible with the corresponding
diameter EEA™ XL stapler length products only; the EEA™ OrVil™ anvil 21 mm (aqua) is compatible
with the EEA™ XL stapler 21mm and the EEA™ OrVil™ anvil 25 mm (white) is compatible with the
EEA™ XL stapler 25 mm . They are not compatible with the 22 cm long products or any other EEA™
staplers.
1. The advancing proximal guide suture is supplied in a reel and can be deployed as needed.
K) ADVANCING PROXIMAL GUIDE SUTURE
L) REEL
2. Insert bulb tip of the delivery tube into appropriate structure (e.g. Esophagus).
3. Advance the delivery tube to where the anastomosis is desired.
3a. Ensure reel is retained outside of the patient during the entire process. Deploy suture from reel as needed to ensure
reel is controlled outside patient with no contact with unwanted surfaces.
The proximal guide suture can be used to provide proximal control to facilitate the advancement of the delivery tube and
attached anvil. In the event that an obstruction impedes the passage of the tube and anvil, the proximal guide suture can
be used to facilitate repositioning or removal of the delivery tube and attached anvil.
4. Create an incision in the structure to allow the bulb tip (or white accessory fitting) to pass through.
5. Apply gentle traction when advancing the delivery tube until the plastic collar on the anvil center rod is visible and has
passed incision point. Hold center rod securely with a grasping device.
WARNING: In the event that an obstruction impedes the advancement of the delivery tube, do not
apply excessive force as this may result in tissue damage or detachment of the delivery tube from
the anvil center rod.
6. Cut only ONE leg of the anvil retaining suture and separate the delivery tube from the anvil assembly.
WARNING: Improper cutting and removal of anvil retaining suture could leave the suture in place,
which may result in the suture being stapled to the anastomotic site.
7. Remove delivery tube with retention suture attached. Removal of the tube will pull the suture from the anvil (providing
only one leg of the suture has been cut.)
WARNING: The delivery tube should be carefully inspected after removal to ensure the retaining
suture has been removed with the delivery tube.
8. Attach the center rod of the anvil assembly to the EEA™ XL stapler. Once attached, the anvil head will un-tilt to allow
for parallel closure.
WARNING: When mating the anvil with the stapler, ensure that the anvil center rod is aligned with
the integrated trocar of the stapler.
Do not grasp/clamp on the legs (open end) of the anvil/center rod assembly. Doing so can bend the legs and make it
difficult to attach/detach the anvil to the integrated trocar of the stapler. When attaching the anvil to the instrument, hold
the black twist knob on the handle of the instrument firmly to prevent the integrated trocar from moving back slightly into
the head of the device. This is especially important when using an EEA™ OrVil™ device.
8a. Slowly close the instrument until instrument is fully approximated.
9. Refer to the instructions for use for the EEA™ XL stapler for specific indications, contraindications, warnings, precautions,
and operating instructions.
WARNING: Failure to control the advancing proximal guide suture may result in the suture being
stapled to the anastomotic site.
10. Once firing has been performed as outlined in the instructions for the EEA™ XL stapler, remove the advancing proximal
guide suture from the oral cavity by pulling the suture reel. Pulling the suture reel will pull the advancing proximal
guide suture from the anvil.
WARNING: The anvil head and suture reel should be inspected after removal to ensure the
advancing proximal guide suture has been removed with the suture reel.
Use of the white accessory fitting (on a shortened delivery tube):
11. If a shorter length of the delivery tube is desired, the tube may be cut to the appropriate length.
12. Secure the white accessory fitting at the cut end of the delivery tube by pushing the barbed section of the fitting into
the tube until it is fully seated. Ensure the fitting is fully seated and secure in the tube prior to use.
WARNING: A shortened delivery tube is not for use in transoral applications.
13. Follow instructions 3 through 9 above.
STORE AT ROOM TEMPERATURE.
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
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2022 - 06 / 01