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 TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU). THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE AQUABEAM ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR AB2000-D/SERIAL NUMBER (B)(6) WAS CONDUCTED, 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 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. THE TREATING SURGEON INADVERTENTLY CUT THE PATIENT¿S URETERAL ORIFICES WITH THE LOOP. AS A RESULT, THE SURGEON PLACED URETERAL STENTS IN BOTH OF THE PATIENT'S URETERAL ORIFICES. THE PATIENT HAS BEEN DISCHARGED AND WILL RETURN FOR STENT REMOVAL. 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 TREATMENT LOG FILES, 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 HEMOSTASIS, THE TREATING SURGEON INADVERTENTLY CUT THE PATIENT¿S URETERAL ORIFICES WITH THE LOOP. AS A RESULT, THE SURGEON PLACED URETERAL STENTS IN BOTH OF THE PATIENT'S URETERAL ORIFICES. THE PATIENT HAS BEEN DISCHARGED AND WILL RETURN FOR STENT REMOVAL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.