AQUABEAM ROBOTIC SYSTEM
Received Dec 23, 2025 · Event occurred Dec 10, 2025
Report 3012977056-2025-00304 · MDR key 23879863
Device
Product problems
- Visual Prompts will not Clear
- Visual Prompts will not Clear
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPONENT CODE: 4756. AQUABEAM CONSOLE, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM. 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 (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE AQUABEAM CONSOLE EXPERIENCED A SYSTEM FREEZE WITH AN UNKNOWN ERROR MESSAGE AFTER THE FIRST TREATMENT PASS. AS A RESULT, A SECOND AQUABLATION PASS COULD NOT BE PERFORMED. THE SURGEON COMPLETED THE PROCEDURE USING A RESECTION LOOP. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.