HYDROS ROBOTIC SYSTEM
Received Jun 18, 2026 · Event occurred May 28, 2026
Report 3012977056-2026-00125 · MDR key 25547521
Device
Product problems
- Electrical /Electronic Property 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, DURING AQUABLATION THERAPY WHILE THE PATIENT WAS IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, THE HYDROS ROBOTIC SYSTEM EXPERIENCED AN ELECTRICAL ISSUE. DUE TO THIS ISSUE, THE TREATING SURGEON OPTED TO CONVERT THE PROCEDURE TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THE PATIENT EXPERIENCED NO ADVERSE HEALTH EFFECTS AS A RESULT OF THIS EVENT.