AQUABEAM ROBOTIC SYSTEM
Received Apr 28, 2026 · Event occurred Mar 30, 2026
Report 3012977056-2026-00094 · MDR key 25021886
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Dehydration
- Hemorrhage/Blood Loss/Bleeding
- Low Blood Pressure/ Hypotension
Narrative
Additional Manufacturer Narrative
ROOT CAUSE OF THE REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN-PROCESS. 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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR BLEEDING AND ADDRESSED VIA CLOT EVACUATION. WHILE IN THE OPERATING ROOM, THE PATIENT WENT INTO HYPOVOLEMIC SHOCK. THE TREATING SURGEON STATED THAT A COMBINATION OF THE PATIENT NOT BEING PROPERLY HYDRATED BEFORE AND AFTER SURGERY AND AQUABLATION THERAPY CONTRIBUTED TO THE EVENT. THE PATIENT HAS SINCE BEEN DISCHARGED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.