HYDROS ROBOTIC SYSTEM
Received Jun 23, 2026 · Event occurred Jun 10, 2026
Report 3012977056-2026-00131 · MDR key 25594849
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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY, THE HYDROS HANDPIECE DISPLAYED MULTIPLE ERROR CODES. DUE TO THIS MALFUNCTION, SURGEON WAS UNABLE TO COMPLETE THE SECOND PASS OF AQUABLATION THERAPY. THE SURGEON THEN OPTED TO RESECT TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.