BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 24308468 · Received February 10, 2026

    Report

    Report Number
    3012977056-2026-00019
    Event Type
    Death
    Date Received
    February 10, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 10, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE AQUABEAM ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS STILL CURRENTLY IN POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TREATMENT LOG FILES AND INSTRUCTIONS FOR USE (IFU). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR AB2000-B/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 LOG FILES FOR THIS EVENT WERE REVIEWED. NO INSTANCES OF ANY ERRORS WERE OBSERVED BEFORE, DURING, OR AFTER THE TREATMENT PASS AND WAS COMPLETED SUCCESSFULLY. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE (IFU), IFU0101-00, REV. E, WAS REVIEWED. 3. CONTRAINDICATIONS DO NOT USE THE AQUABEAM ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM¿S INTENDED USE. IN ADDITION, DO NOT USE THE SYSTEM IN THE FOLLOWING: - INABILITY TO SAFELY STOP ANTICOAGULANTS OR ANTIPLATELET AGENTS PERIOPERATIVELY. IT WAS REPORTED THAT THE PATIENT PASSED AWAY A FEW DAYS POST AQUABLATION THERAPY. THE TREATING SURGEON CONFIRMED THAT THE PATIENT HAD A HISTORY OF ATRIAL FIBRILLATION (AFIB). NO OTHER DETAILS WERE PROVIDED REGARDING PATIENT'S DEATH DESPITE MULTIPLE ATTEMPTS TO OBTAIN INFORMATION SUCH AS CAUSE OF DEATH. IT IS UNKNOWN IF AUTOPSY WAS PERFORMED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED. THE TREATING SURGEON DOES NOT ATTRIBUTE THIS EVENT TO AQUABLATION THERAPY. BASED ON THE EVENT DETAILS, PLUS A REVIEW OF THE TREATMENT LOG FILES, 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.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT AFTER AQUABLATION THERAPY AND DURING FOCAL BLADDER NECK CAUTERY, THE PATIENT CODED. IT WAS REPORTED THAT MASSIVE CLOTS WERE FOUND IN BOTH THE LEFT AND RIGHT ATRIA. THE PATIENT HAS A HISTORY OF ATRIAL FIBRILLATION (AFIB) AND STOPPED TAKING ANTICOAGULANT MEDICATION (ELIQUIS) 3 DAYS PRIOR TO THE PROCEDURE. ACCORDING TO THE TREATING SURGEON, THE CLOTS WERE IDENTIFIED AS NEW AND LIKELY FORMED WITHIN THE LAST 3 DAYS OF THE PROCEDURE. THE PATIENT WAS TAKEN TO THE CORONARY CARE UNIT (CCU) TO HAVE THE CLOTS IN THE ATRIUM EVACUATED AND REMAINED STABLE. IT WAS REPORTED THAT THE PATIENT PASSED AWAY A FEW DAYS POST-AQUABLATION THERAPY. NO OTHER DETAILS WERE PROVIDED REGARDING THE PATIENT'S DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. PROCEPT HAS MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL DETAILS REGARDING THE PATIENT'S DEATH; HOWEVER, TO DATE, NO ADDITIONAL DETAILS HAVE BEEN RECEIVED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370332 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death