Covidien Signia Stapling System User Manual page 11

System Overview
Warnings
12. The power shell is provided STERILE and is intended for use in a SINGLE procedure
only.
13. The stapler does not directly sense tissue thickness. Select the stapling reload with an
indicated tissue range that is appropriate for the target tissue. Overly thick or thin tissue
may result in unacceptable staple formation.
14. After firing staples and removing the instrument, always inspect the staple line and
the surrounding site for hemostasis and/or leakage. Minor bleeding or leakage may be
controlled by electrocautery or sutures.
15. When dividing major vascular structures, be sure to adhere to the basic surgical
principles of proximal and distal control.
16. Failure to completely fire the stapling reload will result in an incomplete cut and/or
incomplete staple formation, which may result in poor hemostasis and/or leakage.
Component-Specific Warning and Precautions
Refer to component specific Instructions for Use for specific individual component
warning and precautions.
Adverse Reactions
Adverse reactions, adverse events and potential complications may include but are
not limited to:
• seroma/hematoma
• bleeding/hemorrhage/anastomotic leak
• fistula
• infection, which may include intraabdominal abscesses/sepsis
• ischemia
• chronic pain
• allergic reactions
• inflammatory reaction
• visceral adhesions
• nerve entrapment
• tissue erosion
• small bowel perforation
• potential for stricture
• potential for delayed gastric emptying, and the need for future re-operation.
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