Cook Medical G31583 - FORCEPS, BIOPSY, HOT, CAPTUR, HDBF-2.4-230-S, 5/BX

Cook Medical G31583 - FORCEPS, BIOPSY, HOT, CAPTUR, HDBF-2.4-230-S, 5/BX

Captura Disposable Hot Biopsy Forceps

Used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps.

Intended Use

This device is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps.

NOTES

• 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

Contraindications include those specific to the primary endoscopic procedure to be performed in gaining access to the desired biopsy or polypectomy site.

Contraindications to gastrointestinal mucosal biopsy and polypectomy include, but are not limited to: coagulopathy and insufficiently prepped bowel.

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. Potential complications with endoscopic mucosal biopsy or polypectomy include, but are not limited to: transmural burns, thermal injury to the patient, explosion.

Precautions

• Refer to package label for minimum channel size required for this device.
• Endoscope must 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.
• Exercising handle while forceps is coiled may result in damage to forceps.
• Mucosal biopsy and polypectomy should be performed under direct endoscopic visualization.
• Before using this device, follow recommendations provided by electrosurgical unit manufacturer to ensure patient safety through proper placement and utilization of patient return electrode. Ensure a proper path from patient return electrode to electrosurgical unit is maintained throughout the procedure.

Product Inspection

• Uncoil forceps, open and close cups, verifying smooth handle operation and cup action.
• With electrosurgical unit off, prepare equipment. Securely connect active cord to handle and electrosurgical unit.

Instructions for Use

• Endoscopically visualize area to be biopsied or polyp to be removed.
• With cups closed, insert forceps into accessory channel of endoscope.
• Advance forceps in 1-2 cm increments until it is visualized exiting endoscope.
  Note: Keep end of forceps that is extending from accessory channel straight at all times. Allowing forceps to hang from accessory channel may cause damage to device.
• Advance forceps to desired biopsy site or polyp, then open cups and advance into tissue to be biopsied or polyp to be removed.
• Following electrosurgical unit manufacturers instructions for settings, verify desired settings and activate electrosurgical unit.
  Note: Maximum rated input voltage for this device is 1.7 kVp-p in coagulation mode only.
• Using slight pressure on handle, close forceps around tissue or polyp. Isolate tissue by gently pulling away from mucosal wall.
  Caution: When applying current, ensure metal tip of forceps does not come in contact with endoscope. Contact of forceps tip with endoscope may result in grounding, injury to patient and/or operator, as well as damage to endoscope and/or forceps.
• Maintain gentle handle pressure to keep cups closed and gently withdraw forceps from site.
• Continue to apply slight pressure on handle and withdraw forceps from channel. While withdrawing forceps from endoscope, wipe excess secretions from cable.
• Prepare specimen for examination per institutional guidelines.
• Upon completion of procedure, turn electrosurgical unit off, disconnect active cord from handle, then dispose of device per institutional guidelines for biohazardous medical waste.

Device Characteristics