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 AQUABLATION THERAPY, THE HYDROS ROBOTIC SYSTEM DISPLAYED ERROR E451 - SYSTEM COMMAND EXCEEDED ATTEMPTS (3 ATTEMPTS). THE CUSTOMER ATTEMPTED TO CLEAR THE FAULT, RESTART THE SYSTEM, AND RE-PRIMING, BUT THE ERROR PERSISTED. DUE TO THE INABILITY TO RESOLVE THE ISSUE, THE TREATING SURGEON DECIDED TO PROCEED WITH CAUTERY USING THE RESECTOSCOPE AFTER ONE PASS. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT FROM THIS EVENT.