Duette™ Multi-Band Mucosectomy Animation

Duette® Multi-Band Mucosectomy Device

INSTRUCTIONS FOR USE (IFU):

https://www.cookmedical.com/data/IFU_PDF/IFU0026-9.PDF

MORE INFO:

https://www.cookmedical.com/product/-/catalog/duette-multi-band-mucosectomy?ds=esc_duette_webds

INTENDED FOR USE: This device is for endoscopic mucosal resection in the upper GI tract. This device is intended for single use only.

DEVICE DESCRIPTION: The device consists of two complementary components: a banding device for creation of the pseudopolyp and a monopolar electrosurgical snare used in conjunction with an electrosurgical unit to remove the pseudopolyp using electrocautery. The banding component is supplied non sterile. The snare is supplied sterile.

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.

If the 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. Notify Cook for return authorization. Do not use this device for any purpose other than stated intended use. This device must be stored in a dry location, away from temperature extremes.

CAUTION: U.S. Federal Law restricts this device to sale by or on the order of a physician.

CONTRAINDICATIONS: Contraindications include those specific to the primary endoscopic procedure to be performed in gaining access to the desired site for mucosal resection. Contraindications specific to esophageal banding include, but are not limited to: cricopharyngeal or esophageal narrowing or stricture, tortuous esophagus, esophageal varices, diverticula, known or suspected esophageal perforation, asymptomatic rings or webs, coagulopathy. Contraindications to upper GI electrosurgical resection include, but are not limited to: coagulopathy.

POTENTIAL COMPLICATIONS: Potential complications associated with EMR include, but are not limited to: retrosternal pain, nausea, laryngeal laceration, esophageal perforation, stricture formation, obstruction, haemorrhage.

PRECAUTIONS: Refer to the package label for the minimum channel size required for this device.

The Duette® Multi-Band Mucosectomy device should only be used by, or under the supervision of, physicians thoroughly trained in therapeutic endoscopy and mucosal resection. The snare component of the Duette® meets the recognized standard for high frequency electrosurgical leakage current (ANSI/AAMI HF 18).

Before using this device, follow the recommendations provided by the electrosurgical unit manufacturer to ensure patient safety through the proper placement and utilization of the patient return electrode. Ensure a proper path from the patient return electrode to the electrosurgical unit is maintained throughout the procedure.

WARNINGS: Failure to isolate the tissue to be biopsied or the pseudopolyp to be removed by pulling it away from the mucosal wall may result in fulguration of normal mucosa and/or perforation.

Contact of the snare wire with the endoscope during electrosurgery may cause grounding, which could result in injury to the patient and/or operator as well as damage to the endoscope and/or snare wire.

Use of ligation bands is contraindicated in patients with a known hypersensitivity to latex.