Remanufactured LigaSure Exact Dissector, Without Nano-coating
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Troubleshooting
The following is a list of troubleshooting suggestions for situations encountered when using the instrument with compatible
Covidien vessel sealing generators. For details on specific situations, refer to the corresponding generator user’s guide or the
generator quick reference guide.
Alert Situations
When an alert condition occurs, energy delivery stops. After the alert condition has been corrected, energy delivery will be
immediately available.
Troubleshooting Information
The following is a list of troubleshooting suggestions for situations encountered when using the instrument with compatible
Covidien vessel sealing generators. For details on specific situations, refer to the corresponding generator user’s guide or
the generator quick reference guide.
Alert situations
When an alert condition occurs, energy delivery stops, the generator produces a sequence of
pulsed tones, and an alert will be displayed on the generator.
Do Not Cut the Vessel.
The user
should inspect the seal site and instrument before proceeding. After the alert condition has been
corrected, energy delivery will be immediately available.
Troubleshooting
steps
1.
Release the footswitch pedal or activation button, if still engaged.
2.
Open the instrument jaws and inspect for a successful seal.
3.
Follow the suggested corrective actions on the generator screen, the generator quick
reference card, or in the generator user’s guide.
4.
If possible, reposition the instrument and regrasp tissue in a location that overlaps the
previous seal, then reactivate the seal cycle.
Reasons for alert
Too little tissue between the jaws
– The user is grasping thin tissue or not enough tissue; open
the jaws and confirm that a sufficient amount of tissue is inside the jaws. If necessary, increase the
thickness of the tissue that is grasped and reactivate the seal cycle.
Too much tissue between the jaws
– The user is grasping too much tissue; open the jaws, reduce
the amount of tissue tat is grasped, and reactivate the seal cycle.
Activating on a metal object
– Avoid grasping objects, such as staples, clips, or encapsulated
sutures in the jaws of the instrument.
Dirty jaws
– Use a wet gauze pad to clean surfaces and edges of instrument jaws.
Excess fluids in the surgical field
– Minimize or remove excess fluids from around the
instrument jaws.
Activation switch release before seal complete tone
– The footswitch or activation button was
released before the seal cycle was complete.
Maximum seal cycle time has been reached
– The system needs more time and energy to
complete the seal cycle.
After Surgery
Discard the instrument after use according to the facility’s policy for biohazards and sharps.
Do not resterilize.
Pre-Clinical Studies
Notice
There is no animal data qualified to predict the effectiveness of this device in sealing vessels containing atherosclerotic plaque.
Product performance of the device was established in a chronic in-vivo porcine model. The results showed that no animals
studied experienced an hemostatic complications related to the device during the 21-day survival period. A variety of tissue
types and vessels was evaluated to demonstrate effective sealing in arteries and veins up to and including 7 mm. The United
States clearance of this device was nor based on human clinical testing.
In Vivo Vessel Performance (Chronic)
Vessel Type
Tissue/Vessel Name Vessel Size Range
A/V Bundle
Gastrosplenic
6mm
Short Gastric
3mm - 7mm
Ovarian Pedicle
2mm – 6mm
Artery
Splenic
5mm – 7mm
Renal
3mm – 7mm
Vein
Renal
6mm
