symmetry surgical McCartney Trans Vaginal Tube with 3 Way valve and Silicone Tie Instruction Manual

: June 8, 2024
: Symmetry Surgical

Table of Contents

McCartney Trans Vaginal Tube with 3 Way valve and Silicone Tie
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McCartney™ / ColpotomizOR Tube™
Trans-vaginal Tube with 3-way valve and Silicone tie
35-TV/ 45-TV/ C35-TV/ C45-TV
Instruction Manual

McCartney Trans Vaginal Tube with 3 Way valve and Silicone Tie

INDICATIONS FOR USE / CLINICAL BENEFITS
The McCartney™ / ColpotomizOR Tube™ is used in laparoscopic gynecological procedures. It is intended for insertion under direct visualization for secondary port location. The device can be inserted trans-vaginally to establish path of entry for minimally invasive instruments, and it can be used as a template for dissection for gynecologic surgical procedures. The McCartney™ / ColpotomizOR Tube™ is a conduit for the extraction of specimens.
The device is anatomically shaped for atraumatic insertion. It allows definition and visualisation of vital structures around the cervix/uterus, enabling safer dissection, division, coagulation and suturing of the vaginal cuff. Patients benefit from less pain and discomfort, lower operative and post-operative risks and a faster post-operative recovery.
CONTRAINDICATIONS
Device should not be used in:

Patients with known or suspected pregnancy
Patients with known or suspected uterine or tubal infection,
Patients with early stage cervical malignancy undergoing a laparoscopic approach.

CAUTIONS / WARNINGS
All users must read and be familiar with all instructions, warnings, contraindications and precautions in this package insert before using the device.

This device should be used only by surgeons trained in intrauterine surgery, laparoscopic surgery, diagnostic procedures, gynecological pelvic anatomy, and placement of intrauterine retracting instruments.
Device designed for short term use but not for more than 24 hours.
Caution should be exercised in patients with gynecological malignancy.
Caution should be exercised when using this device in patients who have undergone preoperative and/or intraoperative radiation therapy, have traumatized tissues, or have undergone previous ablation procedures.
Lubricate the bevelled end of the McCartney™ / ColpotomizOR Tube™ before insertion.
Vaginal delivery of a large uterus may result in patient injury. Methods to reduce the size of the uterus prior to removal through the vaginal canal should be considered.
Caution must be used when using energy devices with this device. Any prolonged direct contact may damage the device.
DO NOT reuse this device. This device is intended for single use only. The design of this device may not perform as intended by the manufacturer if it is reused. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device.
Device is sterile if the package is dry, unopened and undamaged. DO NOT use if the pouch is damaged or the packaged seal is broken.

INSTRUCTIONS FOR USE

Select the appropriate McCartney™ / ColpotomizOR Tube™ size after vaginal examination.
Remove the Tube from its sterile packaging and inspect for damage caused by shipping. Discard if any damage is noted.
Lubricate the bevelled end of the McCartney™ / ColpotomizOR Tube™ with sterile surgical lubricant before inserting the Tube into the vagina and advancing it to the cervix.
The McCartney™ / ColpotomizOR Tube™ should then be secured to the drapes with towel clips and the enclosed silicon tie (even when held by an assistant) (Figure 3).
Before inserting the ManipulatOR™ or other accessory instruments into the valves, the valve site and instrument should be lubricated with sterile lubricant.
If required, a flexible suction tube with internal diameter of 4mm may be connected to the suction port. When a tube is not connected, ensure the suction port is closed using the suction port cap.
After delivering the specimen via the McCartney™/ColpotomizOR Tube™, the Tube should be washed in sterile water before being re-lubricated and re-inserted with the closing suture.
Carefully remove the Tube from the vagina. DO NOT use excessive force to avoid traumatizing the vaginal canal.
Before disposing the McCartney™ / ColpotomizOR Tube™, visually inspect the device to check it is intact. The device should be discarded in bio-hazardous waste as per standard procedure.

Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

2797| Product conforms with requirements of European Medical Device Regulation 2017/745.
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**| Caution, consult accompanying documents.
| Do not re-sterilize.
| Keep away from sunlight.
| Keep dry.
| Single Sterile Barrier System.
| Caution: US Federal Law restricts this device to sale by or on the order of a physician.
| Use-by date.
| Do not use if package is damaged.
| Consult Instructions for Use.
| Not made with natural rubber latex.
| Do not reuse.
` MD**`| Medical Device.
| Method of sterilization using ethylene oxide.
| Single sterile barrier system with protective packaging outside.

Distributed exclusively in USA by:
Symmetry Surgical, 3034 Owen Drive, Antioch, TN 37013, USA Email: [email protected],
Telephone: USA & CANADA +1 800-251-3000 (Monday-Friday, 7:00AM – 5:30PM CST)

The O R Company Pty Ltd, 4/47 Wangara Road, Cheltenham, VIC, 3192, Australia.
www.theorcompany.com
**** OBELIS SA, Bd Général Wahis 53
1030 Brussels, BELGIUM, Tel: +(32) 2 7325954
Issued date: 13-04-2022
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