SurgiMate® Premium Fixed Head

Skin Stapler
RX ONLY
SINGLE PATIENT USE ONLY • DISPOSABLE
NOT MADE WITH NATURAL RUBBER LATEX
Contents sterile unless package has been opened or damaged.

IMPORTANT been opened. Re-sterilization may compromise

Read carefully and completely before use. These the integrity of the skin stapler.
instructions are a reference for the DeRoyal • The disposable skin stapler is provided sterile
SurgiMate Skin Stapler. It is not a guide for for use during a single surgical case.
surgical stapling practices. Carefully inspect device • Do not attempt to reload staples into the stapler.
and packaging before use. • The staples are made of stainless steel and are
not absorbable or dissolvable.
INTENDED USE • The skin stapler should be used for skin closure
The DeRoyal SurgiMate Skin Stapler is intended only of the epidermis and is not intended for
to be used for skin closure of wounds, incisions use within the body or for deeper layers of the
or lacerations of the epidermis. The skin stapler corium (dermis) or other connective tissue.
applies one staple each time the handle is
compressed. The staple points penetrate the skin DIRECTIONS FOR USE
and then turn to form a closed staple, which holds 1. Approximate the tissue with forceps. Two
the tissue of the wound line together. The skin forceps may be used to grasp equal portions of
stapler should be used for skin closure only of the tissue on either side of the wound. The forceps
epidermis and is not intended for use within the are pulled together until the tissue edges are
body or for deeper layers of the corium (dermis) apposed and everted. Hold forceps jaws close
or other connective tissue. The skin stapler is to the stapler jaws for most controllable results.
intended for use by a licensed practitioner. For tighter staple, grasp and present more tissue
on each edge with forceps. One forceps may be
INDICATIONS used to approximate the tissue by grasping a
The DeRoyal SurgiMate Skin Stapler may substantial ridge of centered tissue from both
be used for skin closure in a wide variety of edges of the wound and closing until the edges
surgical procedures including, but not limited are apposed and everted. Approximation may
to, gynecological, orthopedic, cardiovascular, be assisted by applying mild traction with skin
urological, thoracic and plastic surgery procedures. hooks at each end of the wound.
2. Gently place the skin stapler jaws on the skin
PRECAUTIONS surface close to the forceps. Align the staple
When it is not possible to maintain at least 6.5mm placement arrow with the center of the wound.
distance when using staples between the skin The handle of the stapler should be held at an
surface and underlying bone, vessels or viscera, angle of approximately 35° to the surface of the
the use of the skin stapler is contraindicated. skin.
3. The stapler may be held lightly on the skin or
CAUTIONS 1 to 2mm slightly above the skin surface if
• Never reuse or sterilize the disposable skin greater distance between the back span and
stapler handle or staples once the package has tissue surface is desired. Slowly depress the
 handle and squeeze the trigger fully until an WARNINGS
audible “click” is heard to place and form the • It is not necessary to press the skin stapler
staple. The SurgiMate design and staple sizing into the skin to get the proper “bite.” The skin
facilitate visibility of the staple placement. The stapler should just “kiss” the skin surface or be
staple may be “pre-cocked” in any position or raised slightly above the skin surface.
held in a partially closed position by the internal • The skin stapler should be used for skin closure
mechanism of the stapler. only of the epidermis and is not intended for
4. Lift the stapler straight up after each staple use within the body or for deeper layers of the
is placed. The stapler releases staples freely corium (dermis) or other connective tissue.
without manual adjustment to disengage the
staples. CAUTION: Federal U.S.A. law restricts this device
5. Repeat steps 1 through 4, placing the staples to sale or use by or on the order of a physician (or
approximately 1/4” apart until the entire wound properly licensed practitioner).
has been closed. The skin stapler applies one
staple each time the handle is compressed. The WARRANTY
staple points penetrate the skin and then turn to DeRoyal products are warranted for ninety (90)
form a closed staple, which holds the tissue of days from the date of shipment from DeRoyal as
the wound line together. to product quality and workmanship. DEROYAL’S
WRITTEN WARRANTIES ARE GIVEN IN LIEU OF ANY
FORMED STAPLE DIMENSIONS IMPLIED WARRANTIES, INCLUDING WARRANTIES
The staples are produced from surgical grade 316L OF MERCHANTABILITY OR FITNESS FOR A
stainless steel. PARTICULAR PURPOSE.

STYLE DIMENSIONS DIAMETER

Wide 6.5 mm wide x .60mm
4.7mm high
Regular 5.7 mm wide x .53 mm
3.9 mm high

Distributed by:
DeRoyal Industries, Inc.
200 DeBusk Lane, Powell, TN 37849 U.S.A.
888.938.7828 or 865.938.7828
www.deroyal.com

©2015 DeRoyal. All Rights Reserved.

Part # 399744 Revised 6/15