BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 24455490 · Received February 26, 2026

    Report

    Report Number
    3012977056-2026-00032
    Event Type
    Malfunction
    Date Received
    February 26, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 26, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT WHILE THE CUSTOMER WAS SETTING UP, THE ULTRASOUND IMAGE DID NOT APPEAR ON THE CPU, AND THERE WAS NO TRUS SIGNAL. THE CUSTOMER ATTEMPTED TO RESEAT THE CABLE CONNECTION, POWER-CYCLE THE SYSTEM, AND SWAP THE TRUS PROBE, BUT THE ISSUE PERSISTED. AS A RESULT OF THIS ISSUE, THE PROCEDURE WAS CONVERTED TO A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154927 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown