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 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 FOR THIS EVENT WERE REVIEWED. NO ISSUES WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS AND WAS COMPLETED SUCCESSFULLY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000/SERIAL NUMBER (B)(6) WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCE'S, 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 INSTRUCTION FOR USE (IFU) SJ-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 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. 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'S INSTRUCTIONS FOR USE (IFU) LISTS BLEEDING AS A POTENTIAL RISK OF AQUABLATION THERAPY AND PROVIDES ADEQUATE INSTRUCTIONS TO ACHIEVE HEMOSTASIS. BASED ON THE REVIEW OF THE INFORMATION, 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.

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT, ONE MONTH POST-AQUABLATION THERAPY, THE PATIENT ARRIVED TO THE HOSPITAL WITH BLEEDING AND REQUIRED A RETURN TO THE OPERATING ROOM FOR CLOT REMOVAL AND ADDITIONAL CAUTERY TO GAIN HEMOSTASIS. THE PATIENT HAS BEEN DISCHARGED AND IS DOING WELL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.