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 OF THIS EVENT CONSISTED OF A REVIEW OF THE TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND PROCEPT'S RISK DOCUMENTATION. THE HYDROS ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE HYDROS ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) 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 SYSTEM 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. 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 AFTER AQUABLATION THERAPY, THE PATIENT'S LEFT UO COULD NOT BE VISUALIZED. IT WAS NOTED THAT THE TREATING SURGEON MAY HAVE INADVERTENTLY RESECTED THE UO WITH THE RESECTOSCOPE PRIOR TO VISUALIZATION. A FOLEY CATHETER WAS PLACED AND THE PATIENT WAS DISCHARGED. IN ADDITION, THE PATIENT WILL BE MONITORED WITH A VOIDING TRIAL, REPEAT LABS, AND ULTRASOUNDS. 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 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.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT'S LEFT URETERAL ORIFICE (UO) COULD NOT BE VISUALIZED. IT WAS NOTED THAT THE TREATING SURGEON MAY HAVE INADVERTENTLY RESECTED THE UO WITH THE RESECTOSCOPE PRIOR TO VISUALIZATION. A FOLEY CATHETER WAS PLACED, AND THE PATIENT WAS DISCHARGED. IN ADDITION, THE PATIENT WILL BE MONITORED WITH A VOIDING TRIAL, REPEAT LABS, AND ULTRASOUNDS. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.