AQUABEAM ROBOTIC SYSTEM
Received Apr 17, 2026 · Event occurred Mar 25, 2026
Report 3012977056-2026-00086 · MDR key 24912919
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Male
- Respiratory Arrest
Narrative
Description of Event or Problem
A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, POST-AQUABLATION THERAPY, THE PATIENT WAS BEING EXTUBATED AND AWAKENED FROM ANESTHESIA AND WENT INTO RESPIRATORY ARREST. THE PATIENT HAD MUCUS SUCTIONED OUT AND WAS RE-INTUBATED. IT WAS NOTED THAT THE PATIENT HAD A LARGE AMOUNT OF MUCUS PRIOR TO THE PROCEDURE. THEY PLACED THE PATIENT ON A VENTILATOR AND MOVED THEM TO THE POST-ANESTHESIA CARE UNIT (PACU). THE PATIENT WAS REPORTED TO BE DOING WELL AND HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.
Additional Manufacturer Narrative
THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS CURRENTLY IN THE POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE EVENT INFORMATION, DEVICE HISTORY RECORD (DHR), AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE LOG FILES FOR THIS PROCEDURE COULD NOT BE CONDUCTED AS THEY WERE NOT PROVIDED. THREE GOOD FAITH EFFORTS (GFE) WERE MADE TO OBTAIN THE LOG FILES WITHOUT SUCCESS. IF THE LOG FILES ARE MADE AVAILABLE IN THE FUTURE, THEN THIS COMPLAINT WILL BE REOPENED TO CONDUCT SUCH A REVIEW. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-D/SERIAL NUMBER (B)(6) WAS PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), SJ-IFU0101-00, REV. E, WAS REVIEWED AND STATES THE FOLLOWING: 3. CONTRAINDICATIONS DO NOT USE THE AQUABEAM ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IT WAS NOTED THAT THE PATIENT HAD A LOT OF MUCUS BEFORE THE PROCEDURE. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION THERAPY. BASED ON THE EVENT DETAILS PLUS A REVIEW OF THE DHR AND IFU THE EVENT IS CONSIDERED NOT TO BE DEVICE-RELATED. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.