AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS CURRENTLY IN THE 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) FOR AB2000/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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTION FOR USE (IFU), SJ-IFU0101-00, REV C, WAS REVIEWED. 4.3 WARNINGS: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: BLADDER OR PROSTATE CAPSULE PERFORATION. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS BLADDER PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. THE TREATING SURGEON HAD DIFFICULTY INSERTING THE RESECTOSCOPE INTO THE BLADDER. THEY INDICATED THE PERFORATION WAS LIKELY CAUSED BY INSERTION OF INSTRUMENTATION. THERE WAS NO TREATMENT AROUND THE PERFORATION TOWARDS THE BACK OF THE BLADDER. THE PATIENT'S BLADDER WAS SURGICALLY REPAIRED. PATIENT HAS SINCE BEEN DISCHARGED AND DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE DHR, AND IFU, 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 BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT HAD A BLADDER PERFORATION. THE TREATING SURGEON HAD DIFFICULTY INSERTING THE RESECTOSCOPE INTO THE BLADDER. THEY INDICATED THE PERFORATION WAS LIKELY CAUSED BY INSERTION OF INSTRUMENTATION. THERE WAS NO TREATMENT AROUND THE PERFORATION TOWARDS THE BACK OF THE BLADDER. THE PATIENT'S BLADDER WAS SURGICALLY REPAIRED. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.