AQUABEAM ROBOTIC SYSTEM

Description of Event or Problem

A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT, POST AQUABLATION THERAPY, THE PATIENT EXPERIENCED LIGHT DAMAGE TO THEIR URETERAL ORIFICE (UO). THE SURGEON PLACED TWO STENTS IN THE PATIENT'S UO. BASED ON ADDITIONAL INFORMATION FROM THE SURGEON, THE UO WAS ONLY LIGHTLY DAMAGED BY THE RESECTOSCOPE, AND IT IS BELIEVED THE EVENT WAS NOT ATTRIBUTABLE TO AQUABLATION. THERE WERE NO ADDITIONAL SURGERIES/INTERVENTIONS REQUIRED. THE PATIENT HAS BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

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. 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 INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. ALTHOUGH THE AQUABEAM ROBOTIC SYSTEM 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 IN THE USER FACILITY'S POSSESSION. IT WAS REPORTED THAT THERE WAS DAMAGE TO THE PATIENT'S URETERAL ORIFICE (UO). THE SURGEON PLACED TWO STENTS IN THE PATIENT'S UO. BASED ON ADDITIONAL INFORMATION FROM THE SURGEON, THE UO WAS ONLY LIGHTLY DAMAGED BY THE RESECTOSCOPE, AND IT IS BELIEVED THE EVENT WAS NOT ATTRIBUTABLE TO AQUABLATION. THERE WERE NO ADDITIONAL SURGERIES/INTERVENTIONS REQUIRED. THE PATIENT HAS BEEN DISCHARGED. 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. BASED ON THE INFORMATION RECEIVED, 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.