Device Description - COOK Medical NTRAP Instrucciones De Uso

NTRAP® Stone Entrapment and Extraction Device
CAUTION: U.S. federal law restricts this device to sale by or on the order of a physician (or a properly
licensed practitioner).

DEVICE DESCRIPTION

Set contains (set components may vary)
•
Stone Extractor
•
Unidex Handle
INTENDED USE
Used as an endoscopic entrapment and extraction device for calculi and other foreign bodies in the urinary
tract, and to minimize stone migration during laser, ultrasonic, electrohydraulic or pneumatic lithotripsy.
CONTRAINDICATIONS
None known
WARNINGS
None known
PRECAUTIONS
•
Users should be familiar with and experienced in urological endoscopic surgery.
•
Assess calculi or other foreign bodies prior to instrument deployment to ensure that object is not too
large to be removed through the anatomy.
•
If resistance is encountered while attempting to remove calculi or other foreign bodies, release the
object. Do not exert excessive force on the device.
•
Due to the asymmetric nature of the NTRAP, do not torque or rotate the device in vivo.
•
When used in conjunction with holmium: YAG laser, do not fire the laser directly upon the device.
•
This device is conductive. Avoid contact with any electrified instrument.
•
Enclose device in sheath before removing from tray/holder.
POTENTIAL ADVERSE EVENTS
The following complications are possible with the use of stone extraction devices.
•
Tissue perforation
•
Tissue evulsion
•
Edema
•
Hemorrhage
INSTRUCTIONS FOR USE
1. Using aseptic technique, remove the NTRAP from its outer package and place into the sterile field. The
NTRAP operating handle is attached to facilitate opening or closing.
2. Before insertion, retract the NTRAP basket into the sheath.
3. Using direct vision or fluoroscopic control, advance the NTRAP sheath beyond the stone or foreign
object prior to deployment.
4. Deploy the NTRAP by advancing the handle forward while holding the sheath in position. The
device may now be used to minimize stone migration during laser, ultrasonic, electrohydraulic or
pneumatic lithotripsy.
NOTE: When using laser or electrohydraulic lithotripsy, a gap of at least 1 cm should be maintained between
the stone and the NTRAP to prevent device damage.
3
ENGLISH