Potential Complications - COOK Medical EchoTip Ultra Manual

2
ENGLISH
INTENDED USE
This device is used to sample targeted submucosal gastrointestinal lesions through the accessory
channel of an ultrasound endoscope.
This device is indicated for adult use only.
NOTES
Do not use this device for any purpose other than stated intended use.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.
Please read all instructions before using this device.
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.
WARNINGS
This device is supplied sterile and intended for single use only. Attempts to reprocess, resterilize,
and/or reuse may lead to device failure and/or transmission of disease.
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 for return authorization.
Not for use in the heart or vascular system.
Not for use with a wire guide. Use with a wire guide may result in damage to the wire guide or
stripping of the wire guide.
PRECAUTIONS
Refer to package label for minimum channel size required for this device.
When targeting multiple sites, replace device for each site.
Needle must be fully retracted into sheath and thumbscrew on safety ring must be locked at
0 cm mark to hold needle in place prior to introduction, advancement or withdrawal of device.
Failure to retract needle may result in damage to endoscope.
3
2 3
4
5
5
3.
4.