Cook Medical G25238 - FORCEPS, HT MXX, BIO, W/O SPIKE, HMF-2.5-230, EACH

Cook Medical G25238 - FORCEPS, HT MXX, BIO, W/O SPIKE, HMF-2.5-230, EACH

HotMaxx Reusable Hot Biopsy Forceps

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

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.
• 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.
• We recommend this device be sterilized prior to first use following set points included in these instructions. Prior to each subsequent use, device should be cleaned and sterilized following cleaning and sterilization instructions provided in this booklet.

Contraindication

• 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

Additional complications that can occur 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.
• Reusability of a device depends, in large part, upon care of device by user. Factors involved in prolonging life of this device include, but are not limited to: advancing through endoscope accessory channel in short increments, maintaining handle in alignment with endoscope accessory channel, gently withdrawing device from channel, avoiding loops and/or kinks in cable, avoiding use of excessive force, thorough cleaning following instructions included in this booklet.
• This device should never be coiled in less than an 8 inch (20 cm) diameter.