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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING PROCEDURAL SETUP AND WHILE THE PATIENT WAS IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, THE HYDROS ROBOT SYSTEM EXPERIENCED NO CONNECTION WITH THE HYDROS TRUS PROBE AND COULD NOT PROCEED WITH THE PROCEDURE. DUE TO THE MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM, THE TREATING SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.