PrecisionPoint Transperineal Access System

The intended use of the PrecisionPoint Transperineal Access System when used in conjunction with a BK ProFocus 2202 ultrasound system and attached to the ultrasound system’s transrectal transducer, is to facilitate proper needle placement to access the prostate in men age 18 or older.

The PrecisionPoint Transperineal Access System is clinically indicated for use as a needle guide for obtaining core biopsy samples for histological evaluation of prostate abnormalities.

• Do not use in regions where there is an active infection. 
• Not intended for use in bone. 
• Not intended for use in the central nervous system and/or in the central circulatory system. 

• FOR SINGLE USE ONLY. Reuse may result in patient infection or injury. 
• Do not use the Perineologic PrecisionPoint Biopsy Needle Guide with Ultrasound transducers that do not fit into the Needle Guide Clamp or fail to be secured with the Needle Guide Clamp. 
• The clamp on the PPBNG must be fully engaged to prevent the rotation of the PPBNG on the ultrasound probe and to align the PPBNG in the correct orientation in relation to the ultrasound transducers. This is critical to the proper alignment of the biopsy needle in relation to the prostate gland image during the procedure.  
• Patients on anticoagulants and/or patients with bleeding disorders may present risks of post-surgical bleeding. 
• This product should be used by a physician who is completely familiar with the indications, contraindications, limitations, typical findings and possible side effects of core needle biopsy, in particular, those relating to the specific organ being biopsied

• Hematuria 
• Hematoma  
• Infection 
• Lower Urinary Tract Symptoms with Negative Urine Cultures 
• Pain 
• Sepsis 
• Urinary Tract Infection 
• Epidiymo-Orchitis 
• Prostatitis  
• Adjacent tissue injury 
• Non-target tissue, organ or vessel perforation  
• Urinary Retention  
• Bleeding 
• Hemorrhage  
• Hematospermia 
• Epididymitis