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. B, 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. THE TREATING SURGEON INADVERTENTLY RESECTED TISSUE FROM THE PATIENT'S URETERAL ORIFICE DURING FOCAL BLADDER NECK CAUTERY (FBNC). STENTS WERE PLACED ON THE DATE OF THE AQUABLATION. THE PATIENT EVENTUALLY HAD THEIR STENTS REMOVED. THE PATIENT IS DOING WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL. THE ROOT CAUSE OF THIS EVENT IS LIKELY USER ERROR. 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 INFORMATION RECEIVED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, IFU, AND PROCEPT'S RISK DOCUMENTATION, 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

Additional Manufacturer Narrative

CORRECTED THE FOLLOWING FIELDS: 1. REPORT SUBMISSION DUE DATE. 2. G3. DATE RECEIVED BY MANUFACTURER.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING FOCAL BLADDER NECK CAUTERY, THE TREATING SURGEON INADVERTENTLY MADE CONTACT WITH THE PATIENT'S URETERAL ORIFICES. THE PATIENT RECEIVED STENTS ON THE DATE OF AQUABLATION. THE STENTS WERE EVENTUALLY REMOVED. THE PATIENT IS DOING WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.