Covidien Signia Stapling System, User Manual

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System Overview
stapler is compatible with Endo GIA™ single-use reloads and Endo GIA™ single-use
reloads with Tri-Staple™ Technology.
Indications for Use
The Signia™ stapler, when used with Endo GIA™ single-use reloads and Endo GIA™ single-
use reloads with Tri-Staple™ Technology, has applications in abdominal, gynecological,
pediatric, and thoracic surgery for resection, transection, and creation of anastomosis. It
may be used for transection and resection of liver substance, hepatic vasculature, and
biliary structures and for transection and resection of the pancreas.
The Signia™ stapler, when used with Endo GIA™ curved tip single use reloads can be
used to blunt dissect or separate target tissue from other certain tissue.
The Signia™ stapler, when used with Endo GIA™ single use Radial Reloads with
Tri-Staple™ Technology, has applications in open or minimally invasive general
abdominal, gynecologic, pediatric and thoracic surgery for resection and transection
of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e.,
low anterior resection. It may be used for transection and resection of liver substance,
hepatic vasculature and biliary structures and for transection and resection of the
pancreas.
The Signia™ stapler, when used with Endo GIA™ single use reinforced reloads with
Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement, has
applications in abdominal, gynecologic, pediatric and thoracic surgery for resection,
transection of tissue and creation of anastomosis. It may be used for transection
and resection of liver substance, hepatic vasculature and biliary structures, and for
transection and resection of the pancreas.
Contraindications
1. Refer to the Instructions for Use provided with the compatible Endo GIA™ single-use
reloads and Endo GIA™ single-use reloads with Tri-Staple™ Technology for specific
indications, contraindications, warnings, and precautions.
2. Tissue thickness should be carefully evaluated before firing any stapler. Refer
to the Instructions for Use provided with the selected Endo GIA™ single-use
reload or Endo GIA™ single-use reload with Tri-Staple™ Technology for the specific
contraindications regarding compressed tissue thickness for the selected reload.
3. Do not use the Signia™ stapler where adequacy of hemostasis cannot be verified
visually after applications.
4. Do not use any linear cutter on major vessels without making provisions for
proximal and distal control.
5. Do not use the instrument on ischemic or necrotic tissue.