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), AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR AB2000-B/SERIAL NUMBER (B)(6), 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. A REVIEW OF THE LOG FILES FOR THIS PROCEDURE COULD NOT BE CONDUCTED AS THESE WERE NOT PROVIDED. THREE GOOD FAITH EFFORTS (GFE) WERE MADE TO OBTAIN THE LOG FILES WITHOUT SUCCESS. SHALL THE LOG FILES BE MADE AVAILABLE IN THE FUTURE, THEN THIS COMPLAINT WILL BE REOPENED TO CONDUCT SUCH A REVIEW. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. ALTHOUGH THE AQUABEAM ROBOTIC SYSTEM'S LABELING DOES NOT SPECIFICALLY MENTION DAMAGE TO URETERAL ORIFICES, PROCEPT'S RISK MANAGEMENT DOCUMENTATION INCLUDES DAMAGE TO URETERAL ORIFICES AS A CLINICAL EFFECT OF AQUABLATION THERAPY. THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. A ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IT WAS REPORTED THAT DURING FOCAL BLADDER NECK CAUTERY, THE PATIENT'S URETERAL ORIFICE WAS OBSERVED TO BE DAMAGED. AS A RESULT, THE TREATING SURGEON PLACED A URETERAL STENT IN THE PATIENT'S URETERAL ORIFICE. PATIENT STATUS IS UNKNOWN. BASED ON THE REVIEW OF THE INFORMATION PROVIDED PLUS A REVIEW OF THE DHR, IFU, AND PROCEPT'S RISK DOCUMENTATION, 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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING FOCAL BLADDER NECK CAUTERY, IT WAS REPORTED THAT THE PATIENT'S RIGHT URETERAL ORIFICE (UO) WAS OBSERVED TO BE DAMAGED. PATIENT'S LEFT UO WAS UNAFFECTED. AS A RESULT, THE TREATING SURGEON PLACED A URETERAL STENT IN THE PATIENT'S RIGHT URETERAL ORIFICE. DESPITE REPEATED EFFORTS TO OBTAIN AN UPDATE, THE PATIENT¿S CURRENT STATUS REMAINS UNKNOWN AS NO INFORMATION HAS BEEN PROVIDED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.