HYDROS ROBOTIC SYSTEM
Received Apr 11, 2026 · Event occurred Mar 26, 2026
Report 3012977056-2026-00079 · MDR key 24847074
Device
Product problems
- Visual Prompts will not Clear
Patient
NA · 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 HYDROS HANDPIECE TRIGGERED MULTIPLE ERROR CODES. AN ADDITIONAL HYDROS HANDPIECE WAS OPENED, BUT THE PROBLEM CONTINUED, ALONG WITH A MALFUNCTION IN THE HYDROS FOOT PEDAL. DUE TO THESE ISSUES, 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
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.