Intended Use; Potential Complications - COOK Medical EchoTip Ultra Manual

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INTENDED USE

This device is used to access or sample submucosal and extramural
lesions of the gastrointestinal tract, access of the following: the intra- or
extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or
for delivery of injectable materials into tissues through the accessory
channel of an ultrasound endoscope .
NOTES
Do not use this device for any purpose other than stated intended use .
This needle is intended to be used with legally marketed drugs and
devices .
If package is opened or damaged when received, do not use . Visually
inspect with particular attention to kinks, bends and breaks . If an
abnormality is detected that would prohibit proper working condition,
do not use . Please notify COOK Medical for return authorization .
This device can be used together with all ECHO compatible products .
Aspiration syringe not intended to be used for injection .
Store in a dry location, away from temperature extremes .
Use of this device restricted to a trained healthcare professional .
This device is supplied sterile and intended for single use only .
CONTRAINDICATIONS
Those specific to primary endoscopic procedure to be performed in
gaining access to desired site .
Coagulopathy

POTENTIAL COMPLICATIONS

Those associated with gastrointestinal endoscopy include, but are not
limited to: perforation, hemorrhage, aspiration, fever, infection, allergic
reaction to medication, hypotension, respiratory depression or arrest,
cardiac arrhythmia or arrest, damage to blood vessels, nerve damage
and acute pancreatitis .
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