COOK Medical Duette Instructions For Use Manual page 6

ENGLISH
INTENDED 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.
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