AQUABEAM ROBOTIC SYSTEM
Received Jul 10, 2026 · Event occurred Jun 24, 2026
Report 3012977056-2026-00142 · MDR key 25784692
Device
Product problems
- Device Difficult to Setup or Prepare
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
H.6 COMPONENT CODE 4756: PER THE USER MANUAL, THE AQUABEAM CONSOLE, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, CONTROLS THE FUNCTIONALITY OF THE HIGH-VELOCITY WATERJET DELIVERED BY THE AQUABEAM HANDPIECE. 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 CORPORATION BECAME AWARE THAT DURING THE SETUP OF THE AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, ERROR CODE "E02 - CONSOLE ERROR" WAS DISPLAYED. THE ISSUE COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING EFFORTS. AS A RESULT, THE PROCEDURE HAD TO BE ABORTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.