AQUABEAM ROBOTIC SYSTEM
Received Mar 24, 2026 · Event occurred Feb 23, 2026
Report 3012977056-2026-00052 · MDR key 24678177
Device
Product problems
- Visual Prompts will not Clear
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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE AQUABEAM ROBOTIC SYSTEM GENERATED MULTIPLE INSTANCES OF AN "E03 - CONSOLE ERROR." DESPITE TROUBLESHOOTING ATTEMPTS, THE ERRORS PERSISTED AND COULD NOT BE RESOLVED. THE TREATING SURGEON ULTIMATELY MADE THE DECISION TO ABORT AQUABLATION THERAPY AND CONVERTED TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) SURGERY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.