Cook Medical G47742 - FORCEPS, BIOPSY, BRONCH, NO SPIKE, DBF-1.8-S, 10/BX

Cook Medical G47742 - FORCEPS, BIOPSY, BRONCH, NO SPIKE, DBF-1.8-S, 10/BX

Captura Disposable Bronchoscope Biopsy Forceps

Intended Use

This device is intended for use in obtaining biopsy samples in the bronchi and lungs.

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.

Contraindications

Contraindications include those specific to primary bronchoscopy procedure performed in gaining access to desired biopsy site. Contraindications to pulmonary biopsy procedures include, but are not limited to: coagulopathy, failure to gain access to desired site, anatomical variations that increase likelihood of hemorrhage or pneumothorax.

Potential Complications

Potential complications associated with bronchoscopy 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.
• 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 endoscope may occur.
• Gentle pressure must be used when operating forceps handle. Excessive pressure will result in rigidity of forceps, which may damage forceps and/or endoscope.

Product Inspection

• Beginning at handle and moving toward cups, uncoil forceps making sure not to stretch cable. Open and close cups, to verify smooth handle operation and appropriate cup action.
  Note: Exercising handle while forceps is coiled may damage forceps performance characteristics.

Instructions for Use

• Endoscopically visualize area to be biopsied.
• With cups closed, insert forceps into accessory channel of endoscope.
• Advance forceps in 1-2 cm increments until it is endoscopically visualized exiting endoscope.
• Advance forceps to desired biopsy site, then open cups and advance into tissue to be biopsied.
• Using slight pressure on handle, close forceps around 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.
• Prepare specimen for examination following institutional guidelines.

Warning

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.