Contraindications; Potential Complications - COOK Medical EchoTip ProCore HD Gebrauchsanweisung

ENGLISH
EchoTip ProCore® HD Ultrasound Biopsy Needle
IMPORTANT INFORMATION
Please review prior to use.
INTENDED USE
This device is used with an ultrasound endoscope for fine needle biopsy,
(FNB), of submucosal lesions, mediastinal masses, lymph nodes and
intraperitoneal masses within or adjacent to the gastrointestinal tract.
NOTES
Do not use this device for any purpose other than stated intended use.
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.
Store in a dry location, away from temperature extremes.
Use of this device restricted to a trained healthcare professional.

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. Those associated with EUS needle biopsy include
but are not limited to: pain, death, peritonitis, portal vein gas and
thrombosis, pneumoperitoneum and tumor seeding of the needle tract.
WARNINGS
Not for use in the heart or vascular system.
The tip of the needle and stylet are sharp and could cause injury to the
patient or user if not used with caution.
5