HYDROS ROBOTIC SYSTEM
Received Mar 11, 2026 · Event occurred Feb 25, 2026
Report 3012977056-2026-00044 · MDR key 24569389
Device
Product problems
- Electrical /Electronic Property Problem
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPONENT CODE = 4756 - HYDROS FOOT PEDAL, A REUSABLE COMPONENT OF THE HYDROS ROBOTIC SYSTEM, USED TO ALIGN AND ACTIVATE THE HIGH-VELOCITY WATERJET DURING AQUABLATION TREATMENT. 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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, FRAYING OF THE HYDROS FOOT PEDAL CORD CAUSED THE DEVICE TO MALFUNCTION. DUE TO THE MALFUNCTION, THE TREATING SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.