2
Indications
The ENSEAL
®
G2 Articulating Tissue Sealers are indicated for bipolar coagulation and mechanical
transection of tissue during laparoscopic and open procedures.
The devices are bipolar electrosurgical instruments for use with the Generator G11 (GEN11). They are
intended for use during open or laparoscopic, general and gynecological surgery to cut and seal vessels, and
to cut, grasp and dissect tissue during surgery.
Indications for use include open and laparoscopic, general and gynecological surgical procedures (including
urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall
bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where
vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used
on vessels up to (and including) 7mm and tissue and/or vascular bundles as large as will fit in the jaws of
the instruments.
The ENSEAL
®
G2 Articulating Tissue Sealers have not been shown to be effective for tubal sterilization or
tubal coagulation for sterilization procedures. Do not use these devices for these procedures.
Contraindications
The efficacy of the ENSEAL
®
G2 Articulating Tissue Sealer for the indication of contraceptive tubal
coagulation (permanent female sterilization) has not been evaluated and is unknown. The design of the
ENSEAL
®
G2 Articulating Tissue Sealer is significantly different from bipolar designs that are marketed
for the indication of contraceptive tubal coagulation. The design differences may affect the efficacy of the
procedure and failure rates may not be comparable.
Device Description
The ENSEAL
®
G2 Articulating Tissue Sealer is a sterile, single patient use surgical instrument used to
coagulate and transect vessels up to and including 7mm in diameter and tissue and/or vascular bundles. This
device is for soft tissue only. The instrument consists of a grip housing assembly, a rotating and articulating
shaft either 35cm or 45cm in length, a moveable jaw and an I-BLADE
®
in the jaws. The instrument shaft
can be rotated to facilitate visualization and enable easy access to targeted tissue. The instrument shaft,
normally in the straight position, can be articulated using the articulation wheel to gain additional access to
tissue and facilitate additional angles across tissue and/or vascular bundles.
The jaws are in a normally opened position and can be partially or fully closed by squeezing the closing
handle. The jaws have atraumatic teeth for grasping and holding targeted tissue when clamped. Bipolar
energy is delivered to the clamped tissue when the energy activation button is pressed. Fully squeezing
the closing handle advances the I-BLADE
®
the length of the jaws, and the targeted tissue is compressed,
coagulated, and transected. The I-BLADE
®
cannot be advanced to transect tissue without first fully
depressing the energy activation button. The power cord is permanently attached to the device and connects
the instrument to the generator. The ENSEAL
®
G2 Articulating Tissue Sealer is designed for use exclusively
with the Generator G11 (GEN11), packaged separately. Dimensions: Jaw Length, Straight: 20mm, Jaw
Length, Curved: 19mm, Shaft Length: 35cm from Jaw Tip to Shaft Rotation Knob or 45cm from Jaw Tip to
Shaft Rotation Knob, Shaft Diameter: 5mm.
Generator Audible Indicators
Refer to the following table for generator audible feedback tones.
Tone
Description
Action
Tone 1
Continuous steady beeping
Generator On: Device is active.
Tone 2
Continuous steady beeping at
increased pitch
Intermediate: Tissue impedance threshold is reached.
Tone 3
One short beep
End of cycle: I-BLADE
®
fully advanced.
Energy is stopped.
