Open-surgery electrosurgical forceps, single-use

Intended purpose

The Disposable Bipolar Forceps (models SY05P1, SY05P2, SY15P1, SY05F1, SY05F2, SY15F1, SY06P1, SY06P2, SY16P1, SY06F1, SY06F2, SY16F1) are sterile, single-use, hand-held bipolar electrosurgical instruments intended to be connected to a compatible high-frequency (HF) electrosurgical generator operating in bipolar mode. They are used by trained surgeons and surgical staff during open surgical procedures to grasp tissue and to pass high-frequency current between the two forceps tips in order to coagulate tissue and achieve haemostasis at the operative site. Because current passes only between the two tips, energy is confined to the tissue held between them and a patient return (dispersive) electrode is not required. Selected models are irrigating ("flushing") bipolar forceps incorporating a channel that allows sterile normal saline to drip from the tips during coagulation. The saline reduces local tissue temperature, limits thermal spread to adjacent tissue, and prevents tissue from adhering to the tips, supporting smoother, more controlled coagulation. A range of tip shapes and sizes is offered for different surgical applications. The device is used with a bipolar connecting cable that conducts current from the generator jack to the forceps. The device is supplied sterile (ethylene oxide) and is intended for single use only; it must not be reprocessed or reused. It is contraindicated for use with an endoscope, and is compatible with HF electrosurgical generators from a range of manufacturers. Output power should be set as low as practicable to achieve the intended clinical effect. The instrument is intended for transient, intra-operative use and is not implanted.