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 PATIENT'S CATHETER WAS REMOVED ON DECEMBER 1ST AND THEY WERE REPORTED TO BE DOING WELL AND HAVE SINCE BEEN DISCHARGED FROM THE HOSPITAL. THE PATIENT ALSO HAD A UTI WHILE IN THE ICU WHICH IS WHY THE CATHETER WAS STILL IN PLACE. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION THERAPY. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU) LIST EMBOLISM AS POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE EVENT DETAILS, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND IFU, 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 THE SECOND TREATMENT PASS, THE PATIENT¿S BLOOD PRESSURE DROPPED. THE PROCEDURE WAS COMPLETED, BUT THE PATIENT REMAINED HYPOTENSIVE AND A CODE WAS CALLED. CPR AND TREATMENT FOR ATRIOVENTRICULAR (AV) THROMBOSIS WERE INITIATED, AND THE PATIENT WAS TRANSFERRED TO THE ICU FOR CARDIOVASCULAR SUPPORT, INCLUDING ECMO. EVALUATION IDENTIFIED A LARGE CARDIAC CLOT AND ADDITIONAL CLOTS IN THE LEG. THE TREATING SURGEON REPORTED THE PATIENT HAD PREVIOUSLY UNKNOWN PRE-EXISTING CLOTS, ONE OF WHICH MIGRATED TO THE HEART, AND DOES NOT ATTRIBUTE THE EVENT TO AQUABLATION THERAPY. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) AS A RESULT OF THIS EVENT. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

Additional Manufacturer Narrative

THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE IT IS CURRENTLY IN THE 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) 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 DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE PATIENT WAS TAKEN TO THE INTENSIVE CARE UNIT (ICU) AS A RESULT OF THIS EVENT. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION THERAPY. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU) LIST EMBOLISM AS POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE EVENT DETAILS, PLUS A REVIEW OF THE TREATMENT LOG FILES, DHR, AND IFU, 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.