HYDROS ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION CONSISTS OF INFORMATION RECEIVED, PLUS REVIEW OF THE TREATMENT LOGS, DEVICE HISTORY RECORD (DHR) AND LABELING. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER: (B)(6) WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCE'S, 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 LOG FILES WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS, WHICH WAS COMPLETED SUCCESSFULLY. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) UM0401-00-01, US, ENGLISH, REV. C, WAS REVIEWED. ALTHOUGH THE HYDROS ROBOTIC SYSTEM'S LABELING DOES NOT SPECIFICALLY MENTION DAMAGE TO URETERAL ORIFICES, PROCEPT'S RISK MANAGEMENT DOCUMENTATION INCLUDES DAMAGE TO URETERAL ORIFICES AS A CLINICAL EFFECT OF AQUABLATION THERAPY. THE HYDROS ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT DURING AQUABLATION THERAPY, THE WATERJET CAUSED ECCHYMOSIS OF TRIGONE AND SLIGHTLY ROUGHED UP THE LEFT URETERAL ORIFICE (UO). THE SURGEON PLACED A STENT. NO OTHER MEDICAL INTERVENTION WAS NECESSARY. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED. ALTHOUGH THE HYDROS ROBOTIC SYSTEM'S LABELING DOES NOT SPECIFICALLY MENTION DAMAGE TO URETERAL ORIFICES, PROCEPT'S RISK MANAGEMENT DOCUMENTATION INCLUDES DAMAGE TO URETERAL ORIFICES AS A CLINICAL EFFECT OF AQUABLATION THERAPY. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR AND UM, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. 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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE WATERJET CAUSED ECCHYMOSIS OF THE TRIGONE AND SLIGHTLY ROUGHED UP THE LEFT URETERAL ORIFICE (UO). A STENT WAS PLACED BY THE TREATING SURGEON. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.