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 DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES 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-CONFORMANCE'S, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE TREATMENT LOG FILES WERE REVIEWED. AN E43 ERROR WAS OBSERVED TO HAVE OCCURRED AT THE BEGINNING OF SYSTEM START BUT WAS QUICKLY RESOLVED. NO OTHER INSTANCES OF ERRORS WERE OBSERVED AFTERWARDS. 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: BLADDER OR PROSTATE CAPSULE PERFORATION. 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 BLADDER PERFORATION AS A POTENTIAL RISK OF AQUABLATION THERAPY. IT WAS REPORTED BY THE TREATING SURGEON THAT THE PATIENT'S BLADDER PERFORATED FROM BECOMING OVERLY DISTENDED. THE CAUSE IS UNKNOWN; HOWEVER, IT WAS LIKELY DUE TO CLOTS CLOGGING OUTFLOW DURING FOCAL BLADDER NECK CAUTERY (FBNC). 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. 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 (PROCEPT) BECAME AWARE THAT, DURING FOCAL BLADDER NECK CAUTERY (FBNC), THE PATIENT'S BLADDER WAS OVERLY DISTENDED. THE TREATING SURGEON INDICATED THAT THE PATIENT HAD A BLADDER PERFORATION. THE PATIENT WENT TO THE ICU TO RECOVER AND WAS LEFT WITH A CATHETER AND GRAVITY DRAINAGE BAG OVERNIGHT. THE PATIENT WAS REPORTED TO BE RECOVERING WELL AND WAS TRANSFERRED TO A DIFFERENT HOSPITAL BECAUSE THE PATIENT'S FAMILY WANTED A SECOND OPINION. THE CAUSE OF THE PERFORATION IS UNKNOWN, IT WAS LIKELY CAUSED BY THE PATIENT'S OVERLY DISTENDED BLADDER, THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION THERAPY OR THE DEVICE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.