Device Dossier
Suction Irrigation Set - Irrigation tubing set, general purpose
Device Dossier for Suction Irrigation Set - Irrigation tubing set, general purpose (Surgical irrigation tubing set, single-use, Class IIa, sponsor…
- GMDN category: Surgical irrigation tubing set, single-use
Intended purpose
The Unimicro Disposable Suction Irrigation Set is a sterile, single-use, multifunctional instrument intended for the delivery of sterile irrigation solution to, and aspiration of fluids and smoke from, the operative site during laparoscopic surgical procedures to aid visualization. The device is designed to provide controlled suction and irrigation during laparoscopic procedures in conjunction with medical suction equipment (an aspiration pump) and an irrigation fluid supply (normal saline). The pulsatile action of the pump mechanism helps flush blood and tissue debris from the operative site during laparoscopy to aid visualization. The device may also be used for resection of filmy adhesions (hydrodissection) and peritoneal lavage. The device consists of a grip body equipped with two valves (suction valve and irrigation valve), a probe tube, and two catheters (suction catheter and irrigation catheter). One catheter is designed to attach to a supply of irrigation fluid and the other to medical suction equipment. The grip body is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to accommodate a variety of instruments and diameters. The device is available in two series: MSI2 and MSI3. The MSI3 series additionally provides smoke evacuation from the abdominal cavity using negative pressure suction equipment; the MSI2 series does not include this function. Both series are available in 5mm and 10mm probe sizes with double spike tubing. The device is intended for use by trained physicians with adequate knowledge of endoscopic procedures, in patients undergoing laparoscopic surgery. It is contraindicated for use in hysteroscopy, cavity distention, or intra-abdominal irrigation whenever laparoscopy is contraindicated.