Intended Use; Contraindications - COOK Medical Biodesign Gebrauchsanweisung

BIODESIGN® SURGISIS® STAPLE LINE
REINFORCEMENT
Notch
Staple Line Reinforcement with Self-Adhesive

INTENDED USE

The Biodesign® Surgisis® Staple Line Reinforcement is intended for use as
a prosthesis for the surgical repair of soft tissue deficiencies using surgical
staplers. The Staple Line Reinforcement may be used for buttressing
and reinforcing staple lines during lung resection (e.g., wedge resection,
blebectomy, lobectomy, bullectomy, bronchial resection, segmentectomy,
pneumonectomy/pneumectomy, pneumoreduction) and other incisions
and excisions of the lung and bronchus. The Staple Line Reinforcement
can be used for the reinforcement of the gastric staple line during bariatric
surgical procedures of gastric bypass, and for reinforcement of staple lines
during small bowel, mesentery, colon and colorectal procedures. The Staple
Line Reinforcement may be used with anastomotic staplers or with non-
anastomotic staplers.
For Use With
This symbol means the following: The surgical stapler for which
this device is indicated for use.
QTY
This symbol means the following: Quantity of devices per box.
Rx ONLY
This symbol means the following:
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the
order of a physician.
SURGISIS STAPLE LINE REINFORCEMENT
®
Staple Line Reinforcement
This product is intended for use by trained medical professionals.
This device is supplied sterile and is intended for one-time use.

CONTRAINDICATIONS

This Staple Line Reinforcement is derived from a porcine source and should
not be used in patients with known sensitivity to porcine materials.
This Staple Line Reinforcement contains fructose and should not be used in
patients with known sensitivity to fructose.
PRECAUTIONS
• Do not resterilize. Discard open and unused portions.
• Staple Line Reinforcement is sterile if the package is dry, unopened, and
undamaged. Do not use if package seal is broken.
• Discard Staple Line Reinforcement if mishandling has caused possible
damage or contamination or if Staple Line Reinforcement is past its
expiration date.
NOTE: Staple Line Reinforcement may get damaged if foam applicator
is folded.
• Follow the manufacturer's instructions regarding the use of the stapler,
including precautions regarding use with staple reinforcement materials.
• Use stapler loads that allow for combined thickness of tissue and the
Staple Line Reinforcement.*
• Use only specified staplers with appropriate sized Staple Line
Reinforcement.
• Ensure that prior to firing the surgical stapler the entire active portions of
stapler jaws are covered by the reinforcement device.
• Fire the stapler within 20 minutes after applying the Staple Line
Reinforcement. Otherwise, the device may be difficult to dislodge from the
stapler jaws after firing.
• Avoid dropping the tray-device assembly from the pouch onto the sterile
field.
• Avoid using the tail to remove the Staple Line Reinforcement from the tray
as it could lead to premature detachment from the foam applicator.
• Avoid trying to re-adhere the Staple Line Reinforcement to the stapler if it
comes off.
Wings
This symbol means the following: Surgisis®
3
ENGLISH
Tail