AQUABEAM ROBOTIC SYSTEM
Received Jan 5, 2026 · Event occurred Dec 10, 2025
Report 3012977056-2025-00310 · MDR key 23970287
Device
Product problems
- Defective Component
- No Apparent Adverse Event
- Patient Device Interaction Problem
- Device Contaminated at the User Facility
Patient
NA · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT, DURING PROCEDURAL SETUP, THE AQUABEAM HANDPIECE BENT DURING INSERTION AS IT ATTEMPTED TO PASS THE BLADDER NECK AND WAS REMOVED. THE HANDPIECE AND STERILE SCOPE WERE SUBSEQUENTLY PLACED ON AN UNSTERILE TRAY. DUE TO A LACK OF ADDITIONAL STERILE SCOPES, THE CASE WAS ABORTED AND RESCHEDULED FOR THE FOLLOWING DAY. THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
COMPONENT CODE = 4756, STERILE SCOPE. 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.
Additional Manufacturer Narrative
THE AQUABEAM HANDPIECE WAS NOT RETURNED FOR INVESTIGATION. THE EVENT COULD NOT BE CONFIRMED AND ROOT CAUSE REMAINS UNDETERMINABLE DUE TO THE INABILITY TO INVESTIGATE THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT NUMBER 25C02420 AND AB2000-E/ SERIAL NUMBER (B)(6) WAS CONDUCTED, 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. LOG FILES WERE NOT REVIEWED AS IT WOULD NOT PROVIDE ANY RELEVANT INFORMATION. THE AQUABEAM ROBOTIC SYSTEM USER MANUAL, UM0101-00 REV.F. STATES THE FOLLOWING: INSERTION OF THE HANDPIECE IS DETAILED IN SECTION 8.20 OF THE AQUABEAM MANUAL: APPLY SURGICAL LUBRICANT TO AQUABEAM HANDPIECE SHAFT. TURN ON IRRIGATION AND INSERT THE AQUABEAM HANDPIECE TRANSURETHRALLY, ADVANCE 1-2 CM PAST THE BLADDER NECK OR MEDIAN LOBE. AT THIS POINT, ATTACH THE AQUABEAM HANDPIECE TO THE HANDPIECE ARTICULATING ARM WITH THE MAGNETIC BLOCK. TURN OFF IRRIGATION. IF NEEDED, ADJUST TRUS PROBE. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.