INSORB Skin Stapler Manual De Instrucciones

ENGLISH / EN
REF 2 0 3 0
The INSORB Subcuticular Skin Stapler places an absorbable staple horizontally in the
dermis to achieve an everted skin closure. The device presents tissue in the path of two
surgically-sharpened needles to capture a precise 'bite' of dermis on both sides of the
incision. A rigid, u-shaped absorbable staple with cleats secures the closure. INSORB
Staples are made of an absorbable copolymer derived from lactic and glycolic acids which
degrade in vivo by hydrolysis and then metabolized. Absorption begins as a loss of tensile
strength without an appreciable loss of mass. At 10-12 weeks, the staple is approximately
one-half its original mass, and the remainder is absorbed during the subsequent months.
IMPORTANT:
Failure to properly follow the instructions may lead to serious surgical consequences.
These directions are designed to assist in the use of the INSORB Stapler. They are NOT a
reference to surgical stapling techniques.
PRODUCT DESCRIPTION:
The INSORB Subcuticular Skin Stapler is a sterile, single patient use device containing
INSORB Absorbable Staples for skin closure.
INDICATIONS:
Synthetic absorbable INSORB Staples are intended for use in the subcuticular closure of skin
where an absorbable tissue fastener is desired for temporary tissue approximation.
CONTRAINDICATIONS:
1. Do NOT use the staple on scar tissue if an effective tissue capture can not
be achieved.
2. Do NOT place a staple where the needle path is obstructed or a collision with any object
may occur.
3. Do NOT use the staple on tissue which is too thin to permit an effective tissue capture.
4. Do NOT use the staple on tissue which is too thick to permit an effective
tissue capture.
5. Do NOT use when radiopacity is necessary or desired since INSORB staples are
radiotransparent.
6. Do NOT use where prolonged tissue approximation beyond that needed for normal skin
tissue closure is necessary or desired.
PRECAUTION:
TENSION - Placement of deep supporting sutures is required to ensure closure integrity
when excessive tension on the wound edge is or may be present, e.g. high-tension areas,
high BMI, excisions, and/or wounds that may experience significant swelling. These sutures
must be placed at least 1cm from the wound edge to allow sufficient tissue to cover the Blue
Triangles on the nose of Stapler. See graphic at right.
A - Handle
B - Lever
C - Compression Arms
D - Needle Path
E - Blue Triangles
C
F
0.8 mm
I
Staple
:
Dimensions
Post Operative
Strength Profile
1
F - Nose
G - Forceps Mate Location
H - Staple Counter
I - Absorbable Staple
C
E
D
F
G
H
8 mg
3.5 mm
5 mm
60% strength at 7 days
40% strength at 14 days
15% strength at 21 days
A
B