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Circular Stapler
EN
FCSLWAF
READ THE FOLLOWING INFORMATION THOROUGHLY BEFORE USING
PRODUCT.
IMPORTANT NOTES
This booklet is NOT a reference to surgical techniques but a supporting material for the use
of this product, which was designed, tested and produced merely for single patient use. It is
NOT suggested that this device be reused or reprocessed or resterilized due to the risks of
failure, patient injury, contamination as well as patient infection.
DESCRIPTION
The FCSLWAF™ stapler places circular, double staggered rows of titanium staples in the
tissue and resects the excess tissue, thus creating a circular anastomosis. The instrument
can be activated when the handle is squeezed firmly to it limit. There are 6 stapler
diameters in common use, 21 mm, 25 mm, 29 mm, 32 mm, 33 mm, or 34 mm.
INDICATIONS
The FCSLWAF™ staplers can be applied throughout the alimentary tract to create
end-to-end, end-to-side and side-to-side anastomoses.
CONTRAINDICATIONS
1. This device is not designed, sold, or intended for use except as indicated.
2. The FCSLWAF™ stapler should NOT, be used on tissues that would not tolerate
conventional suture materials or conventional closure techniques if so judged by the
surgeon.
3. It is NOT suitable to use the FCSLWAF™ stapler on any tissue that cannot compress
comfortably or by less than the specified compression requirements. These instructions
have to be followed; otherwise, closure failure, tissue trauma, dehiscence, tissue tearing,
and displacement may occur, and/or hemostasis may not be obtained.
4. The instrument should NOT be used if unusual effort is required when turning the
wing-nut for the visualization of the red line in the middle of the green bar in the indicator
window.
5. If the cartridge is too large for the diameter of the structure and the tissue is stretched or
thinned out, the FCSLWAF™ stapler should NOT be used. Leakage and narrowness may
occur in the anastomosis. (Refer to the staple specification chart.)
6. Do NOT use the FCSLWAF™ stapler unless there is enough tissue to allow for proper
inversion of tissue edges and secure placement for staples in the inverted edges.
Purse-string suture has to be tied securely around the purse-string notch on the anvil.
7. Do NOT use the stapler if hemostasis cannot be visually proved after firing.
WARNINGS AND PRECAUTIONS
1. Preoperative radiotherapy may result in tissue thickness to exceed the indicated range