Device Dossier
Aquamantys EVS Epidural Vein Sealer - Open-surgery electrosurgical forceps, single-use
Device Dossier for Aquamantys EVS Epidural Vein Sealer - Open-surgery electrosurgical forceps, single-use (Open-surgery electrosurgical forceps,…
- GMDN category: Open-surgery electrosurgical forceps, single-use
Intended purpose
A sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
Functional description
A sterile, single-use bipolar device that employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. The bipolar sealer handpieces use RF energy from a compatible generator and deliver it to tissue or bone through a conductive fluid (saline). The saline couples the electrical energy output from the electrosurgical generator between the electrodes and to the tissue, increasing the contact area and keeping the surface cool.