Cook Medical G35129 - DEVICE, DUETTE, MULT-BND, MUCOSCTMY, DT-6-5F, EACH

Cook Medical G35129 - DEVICE, DUETTE, MULT-BND, MUCOSCTMY, DT-6-5F, EACH

Duette Multi-Band Mucosectomy

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.

Used for endoscopic mucosal resection in the upper GI tract. The snare component is supplied sterile and the banding component is supplied non-sterile. Intended for single use only.

• Easy set-up, similar to Saeed Six-Shooter Multi-Band Ligator
• Six latex rubber bands for resection of large lesions
• Soft, mini-hexagonal, braided snare cuts cleanly and has excellent shape retention even with repeated resections
• Snare available in 5 FR and 7 FR sizes
• Snare may be passed through ligator handle allowing for speedy resection of ligated tissue without removal of endoscope or disassembly of components

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.

Intended Use

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

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.

Component Parts

• Barrel with preloaded Bands & attached Trigger Cord
• Multi-Band Ligator Handle
• Loading Catheter
• Irrigation Adapter
• Soft, Braided mini-hexagonal snare

System Preparation - Multi-Band Ligator

1. Examine the features of the Multi-Band Ligator handle. The handle has two positions, which control rotation. The firing position (Fig. 1) allows the handle to be rotated in the forward direction only. The two-way position (Fig. 2) allows the handle to rotate in both directions. Prior to introducing the endoscope, keep the handle in the two-way position.
   
2. Insert the Multi-Band Ligator handle into the endoscope accessory channel following the instructions below for the appropriate endoscope. Olympus - (see Fig. 3a), Pentax - (see Fig. 3b), Fujinon - (see Fig. 3c).
   
3. Introduce the loading catheter through the white seal in the Multi-Band Ligator handle and advance, in short increments, until it exits the tip of the endoscope (Fig. 4).
   
4. Attach the trigger cord to the hook on the end of the loading catheter, leaving approximately 2 cm of trigger cord between the knot and the hook (Fig. 5). Withdraw the loading catheter and trigger cord up through the endoscope and out through the Multi-Band Ligator handle. Dispose of the loading catheter per institutional guidelines for biohazardous medical waste.
5. Attach the barrel to the tip of the endoscope, ensuring the barrel is advanced onto the tip as far as possible (Fig. 6).
   
6. With the endoscope tip straight, place the trigger cord into the slot on the spool of the Multi-Band Ligator handle (Fig. 7a) and pull down until the knot is seated in the hole of the slot (Fig. 7b).
   Note: The knot must be seated into the hole or the handle will not function properly.
   
7. With the Multi-Band Ligator handle in the two-way position, slowly rotate the handle clockwise to wind the trigger cord onto the handle spool until it is taut (fig. 8).
   Note: Care must be taken to avoid deploying a band while winding the trigger cord.
   
8. Check the endoscopic view. To maximize visualization, the position of the trigger cord may be altered by rotating the barrel.
   Note: The endoscopic view broadens after each band deployment.

System Preparation - Snare

1. Fully retract and extend the snare to confirm smooth operation of the device.
2. Slide the adjustable marker, located in the handle shaft, to establish a reference point indicating full retraction of the snare into the sheath. The grid on the handle may be used to set up reference points, establishing the thickness of the tissue being excised during the procedure, thereby reducing the possibility of premature guillotining of the pseudopolyp. To utilize these markings, fully advance and retract the snare to establish the markings which indicate snare position for the configuration being used (Fig 11).