EUS sampling of pancreatic mass including pathologist assessment

EUS sampling performed by Dr. Anand Sahai. Pathology assessment performed by Dr. Phillipe Stephenson.
Dr. Anand Sahai was not a paid consultant of Cook Medical at the time this video was made.
Dr. Phillipe Stephenson was not a paid consultant of Cook Medical at the time this video was made.
EchoTip® ProCore™ HD Ultrasound Biopsy Needle.
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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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.
PRECAUTIONS: Refer to package label for minimum channel size required for this device.
Ensure the stylet is fully inserted when advancing the needle into the biopsy site.
When targeting multiple sites, replace device for each site.
Needle must be retracted into sheath and thumbscrew on safety ring must be locked to hold needle in place prior to introduction, advancement or withdrawal of device. Failure to retract needle may result in damage to endoscope.