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 EXCEEDED 120% OF THE DESIRED SPEED FOR OVER 10MS. A NEW AQUABEAM HANDPIECE WAS OPENED FOR THE SECOND TREATMENT PASS, BUT ANOTHER UNSPECIFIED ERROR OCCURRED, AND THE TREATING SURGEON DECIDED TO ABORT THE PROCEDURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

THE HYDROS HANDPIECE WAS NOT RETURNED FOR INVESTIGATION. GOOD FAITH ATTEMPTS WERE MADE BY PROCEPT TO RETRIEVE THE HYDROS HANDPIECE WITHOUT SUCCESS. THE TREATMENT LOG FILES WERE REVIEWED AND FOUND E251, E451, AND E250 ERRORS, CONFIRMING THE REPORTED FAILURE. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE HYDROS HANDPIECE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) AND HYDROS HANDPIECE/LOT NUMBER 25C05373 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED FAILURE. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. 17.2: E250 SYSTEM ALERT 1. RELEASE FOOT PEDAL. 2. CLICK OK TO CLEAR ALERT. 3. IF ALERT PERSISTS, CHECK STATUS PANEL. 4. RECONNECT OR REPLACE COMPONENT IF NEEDED; MAY REQUIRE REALIGNMENT AND REPLANNING IF ISSUE PERSISTS, CALL PROCEPT BIOROBOTICS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.