HYDROS ROBOTIC SYSTEM
Received Apr 21, 2026 · Event occurred Apr 3, 2026
Report 3012977056-2026-00087 · MDR key 24945395
Device
Generic name
Fluid Jet Removal System
Manufacturer
Procept Biorobotics CorporationCatalog number
HY1000T
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 WAS SCHEDULED FOR AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE HYDROS ROBOTIC SYSTEM EXPERIENCED A COMMUNICATION ERROR CODE (E480) WITH THE POWER DISTRIBUTION UNIT. THE ERROR COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS. AS A RESULT, THE TREATING SURGEON MADE THE DECISION TO ABORT THE PROCEDURE AND PROCEED WITH A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT 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.