AQUABEAM ROBOTIC SYSTEM
Received Apr 21, 2026 · Event occurred Apr 3, 2026
Report 3012977056-2026-00088 · MDR key 24945393
Device
Product problems
- Failure to Fire
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A MALE PATIENT WAS SCHEDULED FOR AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE WATER JET WOULD NOT ACTIVATE WHEN THE SURGEON STEPPED ON THE FOOT PEDAL. THE ISSUE COULD NOT BE RESOLVED 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.
Additional Manufacturer Narrative
COMPONENT CODE = 4756; AQUABEAM FOOTPEDAL IS A RE-USABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, WHICH CONTAINS FOOT-ACTIVATED MOTION BUTTON TO ACTIVATE THE HIGH-VELOCITY WATERJET DURING TREATMENT MODE. 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.