INSORB 2030 Mode D'emploi page 2

ADVERSE REACTIONS:
Adverse reactions may include wound separation, infection, bleeding,
hematoma, seroma, skin edge necrosis, pain, acute inflammation, erythema,
edema, swelling, excessive itching, irritation, bruising, drainage, prolonged
wound eversion, surfacing staples, percutaneous staples, superficial staples,
anxiety, and compromised cosmesis, e.g., keloid, hypertrophic scar, scar
widening, discoloration, and hyperpigmentation.
OTHER NOTES:
● FORCEPS - Closure may also be completed with two (2) Adson Forceps or
the INSORB|1 Forceps.
● EXCISIONS - If the Staples are used to close the deep dermal layer in
excisional closures, a subcuticular running stitch placed above the Staples is
encouraged.
● NEEDLE DAMAGE– ANY contact with a forceps or other object WILL cause
damage to the needles and compromise performance. If ANY damage is
suspected, or if the device is not operating smoothly, discard and replace.
● SCAR TISSUE –Full excision of all scar tissue to virgin tissue edges may be
required to achieve an effective wound closure.
INSORB Skin Closure Technique:
INSPECT: Visually inspect for breaches of packaging integrity prior to use.
PREPARATION: Prior to use, remove the red cover by pulling upper thin tab out and forward
GR ASP
1
5 mm
&LI FT
MATE
2
&
FI RE
NOTE: Grasping more than 5mm of tissue and/or not firmly mating the Stapler and forceps may result in placing Staples too deep and/or too far apart which may
compromise wound integrity.
To minimize superficial or external Staple placements:
● Keep Stapler level with plane of skin.
● Ensure both Blue Triangles are covered by skin. If
necessary, rock Stapler side-to-side when in flaccid
tissue or tight spaces, e.g. final Staple placement.
● Reverse the direction of closure for final Staple
placement.
Using 1 Adson forceps, GRASP 5mm of the tissue at an
apex or directly above a previously placed staple* and
LIFT to present tissue to the Stapler.
* To ensure Staples are placed at 7mm intervals
While maintaining the lift, place the nose into the
wound to firmly MATE the Stapler with the Adson
forceps directly below the arrow and FIRE the Stapler
with a smooth squeeze until audible click, then release.
Lift straight up to remove the Stapler - do not pull
backwards.
● REMOVING STAPLE DURING SURGERY - Grasp the back of the staple and
pull firmly to extract.
● POST-OPERATIVE WOUND ACCESS - To partially or fully open the incision,
use scissors to cut the backspan of the Staple(s). It is not necessary to
remove staple fragments.
● SINGLE PATIENT USE - Do NOT resterilize. Staple strength is affected by
heat, humidity, and radiation. Resterilization will compromise performance and
wound integrity, which may result in a wound separation. Properly dispose of
all opened products whether used or unused.
● WOUND CARE – The use of adhesive dressings or skin glue is encouraged
for external wound protection. The INSORB Staple provides an interrupted
closure which allows immediate post-operative drainage that may be noted at
the first dressing change.
● STORE AT 16-25°C (61-77°F)
● DO NOT EXPOSE TO 50°C (122°F) – Avoid prolonged exposure to elevated
temperatures. Do NOT use the staplers if the temperature circle on the front
flap of the carton has changed to RED.
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