AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION CONSISTS OF REVIEW OF TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR) AND LABELLING. 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-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 INSTRUCTIONS FOR USE (IFU), IFU0104-00 REV C WAS REVIEWED AND STATES THE FOLLOWING: 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: BLEEDING OR BLOOD IN THE URINE URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE. 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. NOTE: CONSIDERATIONS FOR CAUTERY: START AT BLADDER NECK. 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. 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 AND URETHRAL DAMAGE CAUSING FALSE PASSAGE OR STRICTURE AS A POTENTIAL RISK OF AQUABLATION THERAPY AND PROVIDES ADEQUATE INSTRUCTIONS ON HOW TO ACHIEVE APPROPRIATE HEMOSTASIS. IT WAS REPORTED THAT THE SURGEON INSERTED THE CATHETER INTO A FALSE PASSAGE IN THE URETHRA MULTIPLE TIMES AFTER FOCAL BLADDER NECK CAUTERY (FBNC). THE COMBINATION OF PROCEDURAL DELAY AND INSERTION OF THE CATHETER INTO THE FALSE PASSAGE CAUSED THE PATIENT TO BLEED, REQUIRING A BLOOD TRANSFUSION. THE PATIENT HAS SINCE BEEN DISCHARGED AND DOING WELL. 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. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. 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, POST AQUABLATION THERAPY, THE SURGEON INSERTED THE CATHETER INTO A FALSE PASSAGE IN THE URETHRA MULTIPLE TIMES. THE COMBINATION OF THE PROCEDURAL DELAY AND THE INSERTION OF THE CATHETER INTO THE FALSE PASSAGE CAUSED THE PATIENT TO BLEED, REQUIRING A BLOOD TRANSFUSION. THE PATIENT HAS SINCE BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.