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Indications
The ECHELON FLEX Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection
of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic,
and pediatric surgical procedures.
Contraindications
•
Do not use the instrument on the aorta.
•
Do not use the instrument on ischemic or necrotic tissue.
•
Do not use any linear cutter on major vessels without making provision for proximal and distal control.
•
Tissue thickness should be carefully evaluated before firing any stapler. Refer to the ECHELON FLEX Powered Vascular Stapler
with Advanced Placement Tip Reload Product Code Chart below for the tissue compression requirements (closed staple height). If
tissue cannot comfortably compress to the closed staple height, or easily compresses to less than the closed staple height, the tissue is
contraindicated as it may be too thick or too thin for the staple identified in the Reload Product Code Chart.
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This instrument is not intended for use when surgical stapling is contraindicated.
•
Do not use the instrument where use of buttress material is indicated.
•
Do not use the instrument if upon closing, the tissue extends beyond the cut line marking, which represents the minimum cut
distance, such as in creating an anastomosis.
•
Do not use the instrument on the parenchyma of the liver, pancreas, kidney, or spleen, or other tissues which cannot comfortably
compress to the closed staple height.
Undesirable Side Effects / Residual Risks
Undesirable side effects and risks associated with surgical stapling include the potential for bleeding, tissue injury, introduction of
non-sterile surfaces or pathogen transfer, inflammatory or unintended tissue reaction, property or environmental damage,
electrical shock, and foreign body magnetic resonance incompatibility. Also, unintended harm, extended surgery, or altered
surgical approach may result from staple line failures, inability to cut, or damaged devices.
Device Description
The ECHELON FLEX Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH ECHELON Vascular White Reload for
Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There
are four staggered rows of staples, two on either side of the cut line. The ECHELON FLEX Powered Vascular Stapler with Advanced
Placement Tip and reloads have a staple line that is approximately 35 mm long and a cut line that is approximately 30 mm long. The shaft
can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to
the operative site.
The instrument is packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for
disposing of the battery pack. Refer to the Battery Pack Disposal section.
The instrument is packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg
points during shipping, transportation, and installation of the reload. The instrument's lockout feature is designed to prevent a used or
improperly installed reload from being refired or an instrument from being fired without a reload.
Caution: Do not load the instrument more than 12 times for a maximum of 12 firings per instrument.
Instrument Product Code Chart
Instrument Code
Description
ECHELON FLEX Powered Vascular Stapler with Advanced Placement Tip
PVE35A
Reload Product Code Chart
WARNING: The ECHELON FLEX Powered Vascular Stapler with Advanced Placement Tip may only be used with the ENDOPATH
ECHELON Vascular White Reload for Advanced Placement Tip, (35mm, 4 Row).
Reload
Open
Code
Staple Height
VASECR35
2.5 mm
Clinical Section
Examples of procedures in which linear cutters and staplers may be used include:
General
• Appendectomy
• Splenectomy
Closed
Staple
Staple Height
Line Length
1.0 mm
35 mm
Gynecologic
• Oopherectomy
Reload
Number
Color
of Staples
White
36
Urologic
• Nephrectomy
• Radical Nephrectomy
1
and resection
Shaft Length
320 mm
Staple
Rows
4
Thoracic
• Lung Resection
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