AQUABEAM ROBOTIC SYSTEM

Additional Manufacturer Narrative

THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE INSTRUCTIONS FOR USE (IFU). NO OTHER INFORMATION WAS MADE AVAILABLE TO PROCEPT ON THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS UNABLE TO BE CONDUCTED AS THE SERIAL NUMBER OF THE AQUABEAM ROBOTIC SYSTEM IS UNKNOWN. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS 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, PENILE OR PELVIC PAIN. 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. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS BLEEDING AND PENILE OR PELVIC PAIN AS POTENTIAL RISKS OF AQUABLATION THERAPY AND PROVIDES ADEQUATE INSTRUCTIONS ON HOW TO ACHIEVE APPROPRIATE HEMOSTASIS. BASED ON THE INFORMATION, PLUS A REVIEW OF THE 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 AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE VIA SOCIAL MEDIA THAT, POST-AQUABLATION THERAPY, A PATIENT EXPERIENCED BLEEDING AND SEVERE PAIN. THE PATIENT RETURNED TO THE HOSPITAL; HOWEVER, IT IS UNKNOWN WHAT TYPE OF ACTION WAS TAKEN TO ADDRESS THE ISSUE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.