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 DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B/SERIAL NUMBER (B)(6) WAS PERFORMED, 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 LOG FILES FROM HOAG HOSPITAL IRVINE FOR THIS PROCEDURE WERE REVIEWED. NO ISSUES WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS AND WAS COMPLETED SUCCESSFULLY. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. 3. CONTRAINDICATIONS: DO NOT USE THE AQUABEAM ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. IT WAS REPORTED THAT PATIENT UNDERWENT AQUABLATION THERAPY AND THAT THE PROCEDURE WENT AS PLANNED, WITHOUT ANY COMPLICATIONS. POST AQUABLATION THERAPY, AND PRIOR TO DISCHARGE, THE PATIENT PASSED AWAY DUE TO ASPIRATING VOMIT WHILE LYING ON HIS BACK. THE PATIENT CODED, AND THE HOSPITAL FOLLOWED THE FAMILY'S "DO NOT RESUSCITATE ORDER." THE TREATING SURGEON DOES NOT ATTRIBUTE THE PATIENT'S DEATH TO THE AQUABLATION THERAPY/DEVICE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. REVIEW OF THE DEVICE HISTORY RECORD, TREATMENT LOG FILES, LABELING/IFU AND INFORMATION RECEIVED THROUGH THE TREATING SURGEON CONFIRMED THAT NO DEVICE MALFUNCTION OCCURRED AND THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED AND WAS USED IN ACCORDANCE WITH ITS INSTRUCTIONS FOR USE. THE REPORTED EVENT WAS DETERMINED 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 AQUABLATION THERAPY WENT AS PLANNED, WITHOUT ANY COMPLICATIONS. POST AQUABLATION THERAPY, AND PRIOR TO DISCHARGE, THE PATIENT PASSED AWAY DUE TO ASPIRATING VOMIT WHILE LYING ON HIS BACK. THE PATIENT CODED, AND THE HOSPITAL FOLLOWED THE FAMILY'S "DO NOT RESUSCITATE ORDER." THE TREATING SURGEON DOES NOT ATTRIBUTE THE PATIENT'S DEATH TO THE AQUABLATION THERAPY/DEVICE. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.