HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE HYDROS TRUS PROBE WAS NOT RETURNED FOR INVESTIGATION. THREE (3) GOOD FAITH EFFORTS WERE MADE BY PROCEPT TO RETRIEVE THE PRODUCT WITHOUT SUCCESS. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE ESTABLISHED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 24C04786 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 EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE HYDROS ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE HYDROS ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. THE DEVICE WAS UNAVAILABLE PER CASE DETAILS. THE EVENT COULD BE CONFIRMED AS A WORK ORDER (WO) WAS PERFORMED AT THE SITE TO RESOLVE THE REPORTED ISSUE. 34 PROCEDURES HAVE BEEN COMPLETED AT THE SITE AFTER THE COMPLETION OF THE WO. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

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. MULTIPLE TROUBLESHOOTING STEPS WERE FOLLOWED, BUT A CONNECTION COULD STILL NOT BE ESTABLISHED. 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.