AQUABEAM ROBOTIC SYSTEM
Received May 27, 2026 · Event occurred May 16, 2026
Report 3012977056-2026-00108 · MDR key 25309278
Device
Product problems
- Visual Prompts will not Clear
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMPONENT CODE 4756 = AQUABEAM MOTORPACK A RE-USABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, DESIGNED TO DOCK WITH THE AQUABEAM HANDPIECE. THE MOTORPACK PROVIDES POWER TO THE AQUABEAM HANDPIECE BY MEANS OF DC MOTORS, WHICH ENABLE BOTH ROTATIONAL AND LONGITUDINAL MOVEMENT OF THE WATERJET PROVIDING CONTROLLED AND PRECISE RESECTION OF THE PROSTATIC TISSUE IN ACCORDANCE WITH THE CPU TREATMENT PLAN. 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 AQUABLATION THERAPY, THE AQUABEAM ROBOTIC SYSTEM GENERATED "E21 - MOTORPACK ERROR" AND "E22 - MOTORPACK ERROR" ERRORS THAT COULD NOT BE CLEARED DESPITE TROUBLESHOOTING ATTEMPTS. AS A RESULT, THE PROCEDURE HAD TO BE ABORTED. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.