Safety Information

Important safety information

All surgical treatments have inherent and associated side effects, some of which may lead to serious outcomes and may require intervention. Individual’s outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics and/or surgeon behavior. The most common side effects are mild and transient and may include mild pain or difficulty when urinating, discomfort in the pelvis or penis, blood in the urine, inability to empty the bladder or a frequent and/or urgent need to urinate, and bladder or urinary tract infection. Other risks include but are not limited to: anesthesia risk; sexual dysfunction, including ejaculatory or erectile dysfunction; injury to the urethra, such as false passage or stricture, or to the rectum, including ressctal incontinence/perforation; bladder or prostate capsule perforation; infection, including the potential transmission of blood borne pathogens; bleeding; incontinence; embolism; electric shock/burn; transurethral resection (TUR) syndrome; bladder neck contracture; and bruising. No claim is made that the AquaBeam Robotic System will cure any medical condition, or entirely eliminate the diseased entity. Repeated treatment or alternative therapies may sometimes be required.

Rx Only

Please review the Instructions for Use and any accompanying documentation for a complete listing of indications, contraindications, warnings, precautions, and potential adverse events.

Indications for use

United States
The HYDROS® Robotic System and AquaBeam® Robotic System are intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia.

Canada, Israel, Taiwan, Japan, China
The AquaBeam® Robotic System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms due to benign prostatic hyperplasia.

EU and UK
The HYDROS® Robotic System and AquaBeam® Robotic System are intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms.

Australia
The AquaBeam® Robotic System is intended for the resection and removal of prostate tissue in males suffering from lower urinary tract symptoms.