Device Dossier

Open-surgery electrosurgical forceps, single-use

Device Dossier for Open-surgery electrosurgical forceps, single-use (Open-surgery electrosurgical forceps, single-use, Class IIb, sponsor Optimed…

Intended purpose

The CoolSealTM Reveal is a sterile, single-use, hand-held bipolar vessel sealing device designed for use with the CoolSealTM Generator. It is a haemostat design with a 5 mm shaft diameter and 10 cm shaft length. The jaw is a curved Maryland-style jaw that rotates. The Reveal creates seals by application of radio-frequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure.

TGA Public Summary