AQUABEAM ROBOTIC SYSTEM
Received Mar 9, 2026 · Event occurred Feb 20, 2026
Report 3012977056-2026-00030 · MDR key 24547146
Device
Product problems
- Connection Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
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 CORPORATION BECAME AWARE THAT DURING THE SETUP OF THE AQUABLATION THERAPY, AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE BUTTONS ON THE FOOT PEDAL WERE NOT WORKING. THE ISSUE COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS. AS A RESULT, THE PROCEDURE HAD TO BE ABORTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.