HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

ROOT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN PROCESS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THREE (3) HYDROS HANDPIECES WERE OPENED DUE TO CONNECTION ISSUES. WHILE TROUBLESHOOTING THE HANDPIECE CONNECTIONS, A TRUS IMAGE ERROR OCCURRED. IT WAS ALSO OBSERVED THAT THE TRUS CONNECTION WAS UNABLE TO STAY SECURE AND REMAINED LOOSE. AS THE ISSUE COULD NOT BE RESOLVED, THE TREATING SURGEON CONVERTED THE PROCEDURE TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.