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 THE FIRST TREATMENT PASS, THE HYDROS ROBOTIC SYSTEM DISPLAYED ERROR E250 - Z ENCODER SPEED IS MORE THAN 120% OF THE DESIRED SPEED FOR OVER 10MS. THE CUSTOMER CLEARED THE ERROR BY REBOOTING. DURING THE SECOND TREATMENT PASS, THE SYSTEM DISPLAYED ERROR E250 AND E251: Z ENCODER SPEED WAS LESS THAN 80% OF THE DESIRED SPEED FOR OVER 10MS. DUE TO THE INABILITY TO RESOLVE THE ISSUE, THE TREATING SURGEON DECIDED TO ABORT THE PROCEDURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.