6
Warnings and Precautions
• Minimallyinvasiveproceduresshouldbeperformedonlybypersonshavingadequatetrainingand
familiarity with minimally invasive techniques. Consult medical literature relative to techniques,
complications, and hazards prior to performance of any minimally invasive procedure.
• Minimallyinvasiveinstrumentsmayvaryindiameterfrommanufacturertomanufacturer.When
minimally invasive instruments and accessories from different manufacturers are employed together
in a procedure, verify compatibility prior to initiation of the procedure.
• Athoroughunderstandingoftheprinciplesandtechniquesinvolvedinlaser,electrosurgical,and
ultrasonic procedures is essential to avoid shock and burn hazards to both patient and medical
personnel and damage to the device or other medical instruments. Ensure that electrical insulation
or grounding is not compromised. Do not immerse electrosurgical instruments in liquid unless the
instruments are designed and labeled to be immersed.
• Failuretoproperlyfollowtheinstructionsmayleadtoserioussurgicalconsequences,suchasleakage
or disruption.
• Beforeusing,removethestapleretainingcapandobservethesurfaceofthereload.Thereloadmust
be replaced with another reload if any colored drivers are visible.
• Theinstrumentjawsmustbeclosedtobeintroducedintothecavitythroughatrocarofthe
appropriate size.
• Whenplacingtheinstrumentthroughthetrocarorincision,avoidadvancingthefiringtrigger
accidentally as this action might activate the lockout. If this occurs, the instrument will not allow
theanvilreleasebuttontoreopentheinstrumentjaws.Torecoverfromthiscondition,removethe
instrument, pull the manual release lever; then press the anvil release button while slowly releasing
theclosingtriggertoopentheinstrumentjawsandreplacethecartridge.
• Whendividingmajorvascularstructures,besuretoadheretothebasicsurgicalprincipleofproximal
and distal control.
• Priortopositioningtheinstrumentjawsontissue,makesurethejawsareintheopenposition.
• Whenpositioningthestaplerontheapplicationsite,ensurethatnoobstructionssuchasclips,stents,
guidewires,etc.arewithintheinstrumentjaws.Firingoveranobstructionmayresultinincomplete
cuttingaction,improperlyformedstaples,and/orinabilitytoopentheinstrumentjaws.
• Ensurethatthetissueliesflatandispositionedproperlybetweenthejaws.Any“bunching”oftissue
alongthereload,particularlyinthecrotchofthejaws,mayresultinanincompletestapleline.The
distal black lines on the anvil and cartridge channel designate the ends of the staple line. The line on
thecartridgechannelthatreads“cut”referencesthecutlineonthedevice.
• Ensuretissuehasnotextended(extruded)beyondtheproximalblacklineontheinstrument.Tissue
forced into the instrument beyond the black line may be transected without staples.
• Iftheclosingtrigger(1)isdifficulttolock,reposition the instrument and take a smaller amount
of tissue. (See Contraindications for appropriate reload selection.)
• TheEndoscopicLinearCutterisamultiple stroke firing device. Three complete strokes of the firing
trigger will advance the staple line a full 45 mm and automatically return the knife blade. The manual
firing release lever will return the knife blade and end the staple line before the full 45 mm staple line
is applied.
• Beforeremovingtheinstrument,besuretissueisclearedfromthejawsandthenclosethejaws.
• Afterremovingtheinstrument,examinethestaplelinesforpneumostasis/hemostasisandproper
stapleclosure.Minorbleedingcanbecontrolledwithelectrocautery,manualsuturesorother
appropriate techniques.
• Theinstrumentmaybereloadedduringasingleprocedure.Donotloadtheinstrumentmorethan
12timesforatotalof12firingsperinstrument.
• Thefiringtrigger(2)andclosingtrigger(1)mustbeintheopenpositionduringreloading.
• Priortoreloadingtheinstrument,holdtheinstrumentinaverticalposition,withanvilandcartridge
jawcompletelysubmergedinsterilesolution.Swishvigorouslyandthenwipetheinsideandoutside
