HYDROS ROBOTIC SYSTEM
Received Apr 3, 2026 · Event occurred Mar 20, 2026
Report 3012977056-2026-00067 · MDR key 24781133
Device
Product problems
- Device Damaged Prior to Use
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPONENT CODE = 4756 - HYDROS MOTORPACK, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM. 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 CORPORATION (PROCEPT) BECAME AWARE THAT DURING PROCEDURAL SETUP AND WHILE THE PATIENT WAS IN THE OPERATING ROOM (OR) UNDER ANESTHESIA, DAMAGE TO THE HYDROS MOTORPACK CABLE WAS NOTED, PREVENTING THE HYDROS ROBOTIC SYSTEM FROM CONNECTING. DUE TO THIS ISSUE, THE TREATING SURGEON ELECTED 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.