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 INSTRUCTION FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR AB2000-B/SERIAL NUMBER (B)(6), 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 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. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTION FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. 4.3 WARNINGS: PROCEDURE AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE: BLEEDING. 8.32 STERILE: A. AFTER THE AQUABEAM HANDPIECE REMOVAL, FOLLOW THE STANDARD CLOT EVACUATION PROCEDURE TO REMOVE CLOTS AND TISSUE WITH A CYSTOSCOPIC SHEATH BY USING AN ELLIK BLADDER EVACUATOR OR TOOMEY SYRINGE. B. USE ONE OF THE FOLLOWING METHODS TO ACHIEVE HEMOSTASIS: CAUTERY FOLLOWED BY FOLEY BALLOON CATHETER INSERTION. UNDER SPINAL ANESTHESIA, INSERT A BALLOON CATHETER IN THE BLADDER WITH BLADDER NECK TRACTION THEN FILL THE BLADDER WITH STERILE SALINE AND MAINTAIN FOR APPROXIMATELY 30-60 MINUTES BEFORE STARTING CBI (CONTINUOUS BLADDER IRRIGATION) BALLOON CATHETER IN BLADDER WITH BLADDER NECK TRACTION BALLOON CATHETER IN PROSTATIC FOSSA: INFLATE BALLOON WITH 5CC IN THE BLADDER. UNDER TRUS GUIDANCE RETRACT BALLOON INTO PROSTATIC FOSSA, INFLATE BALLOON TO 30-50% OF INITIAL PROSTATE VOLUME, APPLY MILD TRACTION ON THE CATHETER TO HOLD THE BALLOON CATHETER IN PLACE, BALLOON CATHETER IN BLADDER, NO TRACTION, C. START CBI PER HOSPITAL PROTOCOL. 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 BLEEDING AS A POTENTIAL RISK OF AQUABLATION THERAPY AND PROVIDES ADEQUATE INSTRUCTIONS TO ACHIEVE HEMOSTASIS. BASED ON REVIEW OF THE EVENT DETAILS, LOG FILES, DHR AND IFU, THE EVENT IS CONSIDERED NOT 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 (PROCEPT) BECAME AWARE THAT DURING POST-FOCAL BLADDER NECK CAUTERY AND PRIOR TO DISCHARGE, THE PATIENT STRUGGLED TO ACHIEVE HEMOSTASIS. THE SURGEON INITIALLY MANAGED THE PATIENT'S BLEEDING WITH TRACTION AND CONTINUOUS BLADDER IRRIGATION (CBI). WHILE THE PATIENT WAS IN THE POST-ANESTHESIA CARE UNIT (PACU), THE SURGEON ORDERED 1G OF TRANEXAMIC ACID (TXA) TO HELP CONTROL THE BLEEDING. THE PATIENT'S HEMOGLOBIN LEVEL DROPPED TO 5.2 G/DL, NECESSITATING A BLOOD TRANSFUSION. AFTER THE TRANSFUSION, THE PATIENT'S HEMOGLOBIN LEVELS RETURNED TO NORMAL. PATIENT IS WELL AND HAS BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.