AQUABEAM ROBOTIC SYSTEM
Received Apr 11, 2026 · Event occurred Mar 11, 2026
Report 3012977056-2026-00080 · MDR key 24848411
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
94 YR · Male
- Cardiac Arrest
- Sepsis
Narrative
Description of Event or Problem
A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE ON (B)(6) 2026, SIX (6) DAYS POST-AQUABLATION THERAPY, THAT THE PATIENT HAD PASSED AWAY. IT WAS REPORTED BY THE TREATING SURGEON THAT THE PATIENT WAS RELATIVELY MORE FRAGILE AND OPTED FOR A DELAYED TRIAL WITHOUT CATHETER (TWOC), FIVE (5) DAYS POST-AQUABLATION THERAPY. THE TRIAL WAS UNSUCCESSFUL, AND THE PATIENT REMAINED CATHETERIZED. NO ISSUES WERE REPORTED AFTER THE PATIENT WAS DISCHARGED. LATER IN THE EVENING ON THE SAME DAY, THE PATIENT DEVELOPED UROSEPSIS, WAS ADMITTED TO A DIFFERENT HOSPITAL, AND GIVEN ANTIBIOTICS. THE FOLLOWING DAY, THE PATIENT WENT INTO CARDIAC ARREST AND PASSED AWAY. THE TREATING SURGEON IS UNABLE TO PROVIDE MORE DETAILS UNTIL AN AUTOPSY IS COMPLETED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.