Cook Medical G53641 - FORCEP, BIOPSY, LG, SPIKE, DBF-2.4SL-230SP-S, 10/BX

Cook Medical G53641 - FORCEP, BIOPSY, LG, SPIKE, DBF-2.4SL-230SP-S, 10/BX

Captura Biopsy Large Forceps

Intended Use

This device is used to obtain endoscopic mucosal tissue biopsies and/or for foreign body retrieval.

• 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 restricted to a trained healthcare professional.

Contraindications

Those specific to the primary endoscopic procedure performed in gaining access to the desired biopsy or retrieval site. Others include, but are not limited to: coagulopathy.

Potential Complications

Those associated with gastrointestinal endoscopy include, but are not limited to: perforation, bleeding or hemorrhage, aspiration, fever, infection, allergic reaction to medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.

Precautions

Refer to package label for minimum channel size required for this device. The endoscope should remain as straight as possible when inserting or withdrawing forceps. Forceps cups must remain closed during introduction into, advancement through, and removal from endoscope. If cups are open, damage to forceps and/or endoscope may occur. Gentle pressure must be used when operating handle of forceps. Excessive pressure will result in rigidity of the forceps, which may damage forceps and/or endoscope.

Warnings

When retrieving a foreign body from upper GI tract, care must be taken to avoid occlusion of airway. These single-use biopsy forceps should only be used to biopsy tissue where possible bleeding or hemorrhage will not present a danger for patients. Adequate plans for management of potential bleeding or hemorrhage and appropriate airway management should be in place. 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. 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.

Product Inspection

Beginning at the handle and moving toward the cups, uncoil the forceps making sure not to stretch the cable. Open and close the cups to verify smooth handle operation and appropriate cup action. Become familiar with the amount of handle movement required to operate the cups. If any irregularities are noted, do not use. Note: Exercising the handle while the forceps is coiled may result in damage to the performance characteristics of the forceps.

Instructions for Use

• Endoscopically visualize area to be biopsied or object to be retrieved.
• With cups closed, insert forceps into accessory channel. Note: Keep end of forceps extending from accessory channel straight at all times. Allowing forceps to hang from accessory channel may cause damage to forceps.
• Advance forceps in short increments until it is endoscopically visualized exiting scope. Note: If resistance is met while advancing forceps, straighten endoscope tip slightly. Do not force forceps through endoscope. If endoscope has an accessory elevator, close elevator before advancing forceps. When resistance is met, open elevator to allow forceps to pass. Use elevator to position forceps.
• Advance forceps to biopsy or retrieval site, then open cups and advance into tissue to be biopsied or object to be retrieved.
• Using slight pressure on handle, close forceps around tissue or object. Note: It is not necessary to apply excessive pressure to cleanly excise tissue. Caution: If forceps fail to close, slowly pull cups against channel opening. Remove endoscope and forceps as a unit, then manually close cups and withdraw forceps from endoscope.
• Maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site. Note: If endoscope has an elevator, open it before withdrawing forceps. If resistance is met while withdrawing forceps, straighten endoscope tip. Do not apply excessive force when removing forceps, as damage to forceps and/or endoscope may occur.
• Continue to apply slight pressure on handle and withdraw forceps from channel. If retrieving a foreign body, gently withdraw forceps until object is against the tip of endoscope. Slowly withdraw endoscope while endoscopically monitoring foreign body. While withdrawing forceps from endoscope, wipe excess secretions from cable.
• Prepare specimen for examination following institutional guidelines.

Upon completion of procedure, dispose of device per institutional guidelines for biohazardous medical waste.