1. Internal Report NAR-VE-17357_1; 2. Internal Report NAR-VE-17353_2; 3. Internal Report NAR-EN-17455_1; 4. Internal Report 16375_2; 5. Developing neonatal minimally invasive surgery: Innovation, techniques, and helping an industry change. Rothenburg S. Journal of Pediatric Surgery 50 (2015) 232-235.; 6. Internal Memo to File - US Regulatory Clearance Search for Vessel Sealers. Important Safety Information
CoolSeal Trinity
The CoolSeal® Trinity sealer/divider/dissector is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal® Trinity sealer/divider/dissector can be used on vessels (arteries, veins, and vascular bundles) up to and including 7mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. Do not use the CoolSeal® Trinity sealer/divider/dissector for tubal sterilization or tubal coagulation for sterilization procedures. This device is contraindicated for use in ENT procedures.
CoolSeal Reveal
The CoolSeal® Reveal open sealer/divider/dissector is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal® Reveal open sealer/divider/dissector can be used on vessels (arteries and veins) up to and including 6mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The CoolSeal® Reveal open sealer/divider/dissector is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics, and tissue bundles 2-3mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. Do not use the CoolSeal® Reveal open sealer/divider/dissector for tubal sterilization or tubal coagulation for sterilization procedures.
CoolSeal Mini
The CoolSeal® Mini sealer is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5mm in diameter for use in adult and pediatric populations, wherever vessel ligation is required. This device is contraindicated for use in ENT procedures. Do not use the device within 1cm of a cochlear implant. Do not use the CoolSeal® Mini sealer for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this device on vessels in excess of 5mm in diameter.
For further information related to warnings, cautions, and directions for use, please consult the Instructions for Use.
