AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING POST-FOCAL BLADDER NECK CAUTERY AND PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED INCREASED BLEEDING IN THE POST-ANESTHESIA CARE UNIT (PACU). AFTER EVALUATION, IT WAS DETERMINED THAT THE PATIENT REQUIRED A RETURN TO THE OPERATING ROOM TO ADDRESS THE BLEEDING THROUGH ADDITIONAL CAUTERY. THE PATIENT¿S CURRENT STATUS AND DISCHARGE DISPOSITION ARE UNKNOWN. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

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 POTENTIAL RISKS OF AQUABLATION THERAPY AND PROVIDES ADEQUATE INSTRUCTIONS ON HOW TO ACHIEVE APPROPRIATE HEMOSTASIS. BASED ON THE REVIEW OF THE INFORMATION PROVIDED, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND IFU, THE EVENT IS CONSIDERED NOT TO BE DEVICE RELATED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR AB2000-B/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 TREATMENT LOG FILE WAS REVIEWED, WHICH CONFIRMED NO MALFUNCTIONS DURING THE AQUABLATION PROCEDURE AND INDICATED THAT THE SYSTEM FUNCTIONED AS DESIGNED. 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 AQUABEAMAQUABEAM 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. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.