AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM 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), AND INSTRUCTIONS FOR USE (IFU). THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR AB2000-D/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 AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), SJ-IFU0101-00, REV. C, WAS REVIEWED. ALTHOUGH THE AQUABEAM 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 AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. IT WAS REPORTED THAT POST AQUABLATION THERAPY, THE PATIENT HAD PERINEPHRIC URINOMA. SURGEON SUPPOSED THAT IT WAS CAUSED BY SOME SORT OF DISTAL URETERAL TRAUMA CAUSING LOW GRADE HYDRONEPHROSIS. REVIEW OF TREATMENT SESSION IMAGES INDICATED THAT THE WATERJET HIT THE PATIENT'S URETERAL ORIFICES (UO) THEREBY CAUSING UO INJURY. A URETERAL STENT WAS PLACED SUCCESSFULLY AND KIDNEY FUNCTION IMMEDIATELY RETURNED TO NORMAL. PATIENT IS DOING WELL AND HAS SINCE BEEN DISCHARGED. NO DEVICE MALFUNCTION WAS REPORTED. 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.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT HAD A PERINEPHRIC URINOMA. THE SURGEON SUSPECTED THAT IT WAS CAUSED BY SOME SORT OF DISTAL URETERAL TRAUMA, CAUSING LOW-GRADE HYDRONEPHROSIS. THE PATIENT WAS ADMITTED FOR FURTHER OBSERVATION. UO INJURY WAS CONFIRMED AND AN URETERAL STENT WAS PLACED THE FOLLOWING DAY, AND KIDNEY FUNCTION IMMEDIATELY RETURNED TO NORMAL. IT WAS REPORTED THAT THE PATIENT IS DOING WELL AND HAS BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.