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 DURING AQUABLATION THERAPY, THE TREATING SURGEON INADVERTENTLY CONTACTED THE PATIENT¿S BILATERAL URETERAL ORIFICES (UOS) DURING TISSUE REMOVAL WITH A RESECTOSCOPE. THE SURGEON ACKNOWLEDGED MISJUDGMENT OF ANATOMIC LOCATION. BILATERAL URETERAL STENTS WERE PLACED AFTER HEMOSTASIS WAS ACHIEVED. NO ADDITIONAL INTRAOPERATIVE COMPLICATIONS WERE NOTED. NO FURTHER INFORMATION WAS AVAILABLE REGARDING THE PATIENT¿S POSTOPERATIVE STATUS. 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 TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU). THE AQUABEAM ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED. 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-B/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 HIT THE PATIENT'S URETERAL ORIFICES (UO). DURING SUBSEQUENT TISSUE REMOVAL USING A RESECTOSCOPE, BOTH URETERAL ORIFICES WERE INADVERTENTLY COMPROMISED DUE TO OPERATOR TECHNIQUE. THE SURGEON ACKNOWLEDGED MISJUDGMENT OF ANATOMIC LOCATION. HEMOSTASIS WAS ACHIEVED. NO FURTHER COMPLICATIONS WERE NOTED. NO ADDITIONAL INFORMATION COULD BE OBTAINED REGARDING PATIENT¿S CURRENT STATUS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.