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 (PROCEPT) BECAME AWARE THAT, DURING AQUABLATION THERAPY, THE HYDROS ROBOTIC SYSTEM DISPLAYED MULTIPLE ERROR CODES. THE FIRST TREATMENT PASS WAS COMPLETED SUCCESSFULLY. ALTHOUGH THE SURGEON CONSIDERED PERFORMING A SECOND TREATMENT PASS, THEY ELECTED TO TRANSITION TO AN OLYMPUS LOOP TO COMPLETE THE RESECTION. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.