AQUABEAM ROBOTIC SYSTEM
Received Jun 30, 2026 · Event occurred Jun 3, 2026
Report 3012977056-2026-00134 · MDR key 25670313
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Cardiac Arrest
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, POST-AQUABLATION THERAPY, THAT THE PATIENT CODED AND HAD TROUBLE BREATHING AFTER WAKING FROM ANESTHESIA. THE PATIENT WAS STABILIZED AND DISCHARGED THE NEXT DAY. THE TREATING SURGEON ATTRIBUTED THE EVENT TO ANESTHESIA AND NOT AQUABLATION THERAPY. NO INFORMATION WAS PROVIDED REGARDING MEDICAL OR SURGICAL INTERVENTION. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.