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 INFORMATION PROVIDED, 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 AQUABEAM ROBOTIC SYSTEM INSTRUCTION FOR USE (IFU) IFU0104-00 REV B, WAS REVIEWED AND STATES THE FOLLOWING: 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 NOTE: CONSIDERATIONS FOR CAUTERY: ¾ START AT BLADDER NECK. ¾ PERFORM FOCAL CAUTERY AT SOURCES OF BLEEDING. SOURCES OF BLEEDING MAY BE COVERED UP BY RESIDUAL TISSUE ABLATED BY THE WATERJET (¿FLUFFY TISSUE¿). IN ORDER TO CHECK FOR ALL SOURCES OF BLEEDING, FIRST USE THE LOOP TO REMOVE FLUFFY TISSUE. ¾ TURN OFF IRRIGATION AND INSPECT FOR SOURCES OF BLEEDING UNDER NORMAL BLOOD PRESSURE. C. START CBI PER HOSPITAL PROTOCOL. DO NOT ALLOW IRRIGATION FLUID BAGS TO BECOME EMPTY. MONITOR EFFLUENT COLOR. 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 THE REVIEW OF THE INFORMATION PROVIDED 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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, FOLLOWING AQUABLATION THERAPY, THE PATIENT WAS BLEEDING AND REQUIRED RETURN TO THE OPERATING ROOM FOR CLOT EVACUATION. THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.