AQUABEAM ROBOTIC SYSTEM
Received Jan 27, 2026 · Event occurred Jan 13, 2026
Report 3012977056-2026-00010 · MDR key 24193257
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 AN "E22 - MOTORPACK ERROR" AND COULD NOT BE CLEARED 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.