Instinct™ Endoscopic Clip Animation

Instinct™ Endoscopic Clip
INSTRUCTIONS FOR USE (IFU):
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MORE INFO:
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INTENDED USE: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal/submucosal defects less than 3 cm in the upper GI tract, bleeding ulcers, arteries less than 2 mm, and polyps less than 1.5 cm in diameter in the GI tract. This device is not intended for the repair of GI tract lumenal perforations.
NOTES: This device is designed for single use only. Attempts to reprocess, resterilize, and/or reuse may lead to device failure and/or transmission of disease.
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.
The number of clips required for hemostasis may vary depending upon anatomical site, histology, lesion type, and patient condition and history. A sufficient quantity of clips should be prepared in consideration of all of these factors prior to procedure.
CONTRAINDICATIONS: Those specific to primary endoscopic procedure to be performed in gaining access to desired site.
Those specific to endoscopic hemostasis include, but are not limited to: uncooperative patient, coagulopathy, cricopharyngeal or esophageal narrowing or stricture, and tortuous esophagus.
POTENTIAL COMPLICATIONS: Those associated with gastrointestinal endoscopy and endoscopic hemostasis include, but are not limited to: perforation, hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest, hematemesis, transient dysphagia, aspiration pneumonia, wound dehiscence, minimal acute inflammatory tissue reaction, transitory local irritation, migration of clip into the bile duct, and anatomy disruption.
PRECAUTIONS: Refer to package label for minimum channel size required for this device.
Endoscope must remain as straight as possible when inserting or withdrawing device.
Clip must remain closed during introduction into, advancement through and removal from endoscope. If clip is open, damage to clip and endoscope may occur.
Exercising handle while clip is coiled may result in damage to clip.
Endoscopic hemostasis should be performed under direct endoscopic visualization.
Clipping hard or severely fibrotic lesions to achieve hemostasis may be more difficult.
If clip deployment device is used with endoscope in a torqued or retroflexed position, clip deployment difficulties can occur.
Removing undeployed device through a retroflexed scope can cause detachment of the clip.
Lesions located in esophagus and lesser curvature of stomach may be difficult to treat with a forward-viewing endoscope.
Treatment of esophageal varices may require clipping in combination with a sclerosing agent.
Use of clips in presence of bacterial contamination may potentiate or prolong infection.