Potential Complications - COOK Medical Soehendra Manual

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ENGLISH
INTENDED USE
This device is used to mechanically crush stones in the biliary duct when
other methods of endoscopic removal have failed.
NOTES
Do not use this device for any purpose other than the stated intended use.
Store in a dry location, away from temperature extremes.
Handle and cable are sold separately.
SLH-1 is compatible with the following lithotripsy cables: SLC-2, TTCL-1,
and TTCL-10.
CONTRAINDICATIONS
Those specific to ERCP and mechanical lithotripsy.
Those associated with biliary stone extraction include, but are not limited
to: an ampullary opening inadequate to allow for the unimpeded passage
of the stone and basket.

POTENTIAL COMPLICATIONS

Those associated with ERCP include, but are not limited to: pancreatitis,
cholangitis, sepsis, perforation, hemorrhage, aspiration, fever, infection,
hypotension, allergic reaction to contrast or medication, respiratory
depression or arrest, cardiac arrhythmia or arrest.
Those associated with basket extraction include, but are not limited to:
impaction of the object, localized inflammation, pressure necrosis.
PRECAUTIONS
Wire cutters must be available when using this device.
Assessment of the stone size and ampullary orifice must be made to
determine necessity of sphincterotomy prior to this procedure. The
length of the intramural segment must be evaluated before determining
advisability of mechanical lithotripsy. In the event a sphincterotomy is
required, all appropriate cautions, warnings and contraindications must be
observed.
Reusability of the device depends in large part on care of the device by
the user. Factors involved in prolonging the life of this device include, but
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