AQUABEAM ROBOTIC SYSTEM
Received Mar 19, 2026 · Event occurred Mar 3, 2026
Report 3012977056-2026-00049 · MDR key 24640255
Device
Product problems
- Device Damaged Prior to Use
Patient
NA · Male
- 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, PRIOR TO AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, THE TREATING SURGEON FOUND THE AQUABEAM CONSOLE'S USB PORT DAMAGED. DUE TO THE DAMAGED PORT, THE AQUABLATION PROCEDURE COULD NOT PROCEED AND WAS RESCHEDULED FOR A LATER DATE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.