AQUABEAM ROBOTIC SYSTEM
Received Nov 24, 2025 · Event occurred Oct 16, 2025
Report 3012977056-2025-00285 · MDR key 23638616
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
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 DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES AND INSTRUCTIONS FOR USE (IFU). 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 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. THE AQUABEAM ROBOTIC SYSTEM'S IFU LISTS BLEEDING AS A POTENTIAL RISK OF AQUABLATION THERAPY AND PROVIDES ADEQUATE INSTRUCTIONS ON HOW TO ACHIEVE APPROPRIATE HEMOSTASIS. IT WAS REPORTED POST-AQUABLATION THERAPY THAT THE PATIENT EXPERIENCED ONGOING BLEEDING AND REQUIRED A BLOOD TRANSFUSION AFTER RESUMING DIRECT ORAL ANTICOAGULANTS (DOAC) ON THE DAY AFTER SURGERY. THE TREATING SURGEON BELIEVES THAT THE INCREASED RISK OF BLEEDING WAS DUE TO THE RESUMPTION OF ANTITHROMBOTIC THERAPY. THE PATIENT HAS NOW RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. BASED ON REVIEW OF THE EVENT DETAILS, PLUS THE TREATMENT LOG FILES, DHR AND IFU, THE EVENT IS CONSIDERED NOT 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 POST-AQUABLATION THERAPY, THE PATIENT EXPERIENCED ONGOING BLEEDING AND REQUIRED A BLOOD TRANSFUSION AFTER RESUMING DIRECT ORAL ANTICOAGULANTS (DOAC) ON THE DAY AFTER SURGERY. THE TREATING SURGEON BELIEVES THAT THE INCREASED RISK OF BLEEDING WAS DUE TO THE RESUMPTION OF ANTITHROMBOTIC THERAPY. THE PATIENT HAS NOW RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL ON THE SAME DAY. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.