AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT THE PATIENT SUSTAINED A BLADDER PERFORATION. IT WAS NOTED THAT THE CAUSE OF THE PERFORATION IS UNKNOWN AND MAY LIKELY BE ATTRIBUTED TO OVERDISTENTION OR A DIVERTICULUM. A CATHETER WAS INSERTED, AND THE TREATING SURGEON NOTED THAT THE PERFORATION WOULD HEAL WITH CONSERVATIVE MANAGEMENT. NO INTERVENTIONS OR SURGERIES WERE PERFORMED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

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, WHICH CONFIRMED NO MALFUNCTION OCCURRED. 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/SERIAL NUMBER 24C00579 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 INSTRUCTION FOR USE (IFU), IFU0104-00, REV. C, WAS REVIEWED. 4.3 WARNINGS: PROCEDURE AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING, SOME OF WHICH MAY LEAD TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: 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 OR PROSTATE CAPSULE PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. IT WAS NOTED THAT THE CAUSE OF THE PERFORATION IS UNKNOWN AND MAY LIKELY BE ATTRIBUTED TO OVERDISTENTION OR DIVERTICULUM. BASED ON THE INFORMATION RECEIVED, PLUS A REVIEW OF THE TREATMENT LOG FILES, 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.