HYDROS ROBOTIC SYSTEM
Received Jan 27, 2026 · Event occurred Jan 7, 2026
Report 3012977056-2026-00008 · MDR key 24191241
Device
Product problems
- Visual Prompts will not Clear
- Connection 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 TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE HYDROS ROBOTIC SYSTEM DISPLAYED ERROR CODE E560 (SOFTWARE ERROR). CONNECTIVITY ISSUES WERE ALSO OBSERVED BETWEEN THE HYDROS ROBOTIC SYSTEM AND THE HYDROS TRUS PROBE. THE SURGEON ATTEMPTED MULTIPLE REBOOTS; HOWEVER, THE ISSUE PERSISTED. THE SURGEON DECIDED TO CONVERT THE PROCEDURE TO TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.