HYDROS ROBOTIC SYSTEM
Received Jun 25, 2026 · Event occurred May 27, 2026
Report 3012977056-2026-00135 · MDR key 25626995
Device
Generic name
Fluid Jet Removal System
Manufacturer
Procept Biorobotics CorporationCatalog number
HY1000T
Product problems
- Adverse Event Without Identified Device or Use Problem
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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT HAD A CATHETER GRADE OF 4-5 INDICATING BLEEDING. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM (OR) FOR ADDITIONAL CAUTERY. NO MALFUNCTION OF THE HYDROS ROBOTIC SYSTEM WAS REPORTED.