Intended Use; Device Description - COOK Medical G22181 Instructions For Use Manual

ENGLISH
14FR COLON DECOMPRESSION SET
CAUTION: U.S. federal law restricts this device to sale by or on the order of a
physician (or properly licensed practitioner).

INTENDED USE

This device is intended for treatment of acute non-toxic megacolon,
pseudo- obstruction (Ogilvie's syndrome) and colonic strictures.

DEVICE DESCRIPTION

Set includes a colon decompression tube, guiding catheter and .035 inch (0.89mm)
wire guide. The colon decompression tube, guiding catheter and wire guide are
radiopaque to aid with fluoroscopic placement.
CONTRAINDICATIONS
Those for colonoscopy include, but are not limited to: fulminant colitis, possible
existing perforation, acute severe diverticulitis, presence of barium or inadequate
bowel preparation.
Those for colon decompression include, but are not limited to: ischemic bowel,
recent rectal surgery, organic colon obstruction, recent surgical anastomosis, acute
myocardial infarction.
POTENTIAL ADVERSE EVENTS
Potential adverse events associated with colonoscopy include, but are not limited
to: allergic reaction to medication, cardiac arrhythmia or arrest, fever, hemorrhage,
hypotension, infection, perforation, respiratory depression or arrest.
Those associated with colon decompression include, but are not limited to:
clogging of the tube, dislodgment of the colon decompression tube / wire guide,
fever and discomfort, hemorrhage, hypotension, infection, migration, pain,
perforation, sepsis.
PRECAUTIONS
The product is intended for use by physicians trained and experienced in
colonoscopy techniques.
Standard technique for the treatment of acute non-toxic megacolon, pseudo-
obstruction (Ogilvie's syndrome) and colonic strictures should be employed.
Refer to package label for minimum channel size required for this device.
Careful history and physical examination must be performed prior to colon
decompression tube insertion in order to determine underlying cause.
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 is restricted to a trained healthcare professional.
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