HYDROS ROBOTIC SYSTEM
Received Jul 16, 2026 · Event occurred Jun 19, 2026
Report 3012977056-2026-00148 · MDR key 25841930
Device
Generic name
Fluid Jet Removal System
Manufacturer
Procept Biorobotics CorporationCatalog number
HY1000T
Product problems
- Visual Prompts will not Clear
Patient
Not reported
- 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 CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE WATER JET POWER LEVEL CAME OUT AT A SIGNIFICANT LEVEL, SOUNDING MORE LIKE 50-100%. THERE WAS AN ERROR CODE (E005 - HIGH PRESSURE PUMP ERROR) AND AN ERROR (E433 COMMUNICATION ERROR) POPULATED ON SCREEN, REQUESTING A REBOOT. WHEN THE TREATING SURGEON WENT IN WITH THE CYSTOSCOPE TO VISUALIZE THE BLADDER FLOOR, FLUFFY WHITE TISSUE WAS NOTED ON THE TRIGONE BETWEEN THE URETERAL ORIFICES (UOS). DUE TO THE PERSISTENT ISSUES, THE PROCEDURE WAS ABORTED WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.
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.