AQUABEAM ROBOTIC SYSTEM
Received Dec 9, 2025 · Event occurred Nov 18, 2025
Report 3012977056-2025-00295 · MDR key 23759091
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
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) DURING THE AQUABLATION THERAPY, WHILE COMPLETING THE FIRST TREATMENT PASS, THE AQUABEAM HANDPIECE GENERATED AN E05 CONSOLE ERROR. THE SURGEON ATTEMPTED MULTIPLE RESTARTS OF BOTH THE CPU AND THE CONSOLE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. CONSEQUENTLY, THE SURGEON ELECTED TO CONVERT THE PROCEDURE AND COMPLETE THE REMAINDER USING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.