AQUABEAM ROBOTIC SYSTEM
Received Jun 9, 2026 · Event occurred May 14, 2026
Report 3012977056-2026-00116 · MDR key 25444111
Device
Product problems
- Visual Prompts will not Clear
Patient
Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS UNDER ANESTHESIA IN THE OPERATING ROOM (OR), THE AQUABEAM MOTORPACK TRIGGERED MULTIPLE ERROR CODES. EXTENSIVE TROUBLESHOOTING WAS PERFORMED; HOWEVER, THE ISSUE PERSISTED. DUE TO THIS ISSUE, THE TREATING SURGEON ELECTED TO ABORT THE PROCEDURE AND RESCHEDULE THE PATIENT FOR A LATER DATE. THE PATIENT EXPERIENCED NO ADVERSE HEALTH EFFECTS AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
COMPONENT CODE = 4756 - AQUABEAM MOTORPACK, 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.