AQUABEAM ROBOTIC SYSTEM

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 PATIENT RECEIVED TWO (2) UNITS OF BLOOD. THE TREATING SURGEON HAD ELECTED TO REMOVE TRACTION IN THE OPERATING ROOM PRIOR TO THE PATIENT¿S ARRIVAL IN THE POST-ANESTHESIA CARE UNIT (PACU). SUBSEQUENTLY, THE PATIENT¿S HEMOGLOBIN LEVEL DECREASED FROM 14 TO 10 G/DL. THE TREATING SURGEON RETURNED TO THE PACU AND REAPPLIED TRACTION, AFTER WHICH THE CATHETER OUTFLOW COLOR IMPROVED FROM GRADE 3 TO GRADE 2 WITHIN FIVE MINUTES. THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

ROOT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN-PROCESS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

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 DEVICE HISTORY RECORD (DHR) AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000/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 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 ON HOW TO ACHIEVE APPROPRIATE HEMOSTASIS. BASED ON THE EVENT DETAILS, 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.