BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 23759091 · Received December 9, 2025

    Report

    Report Number
    3012977056-2025-00295
    Event Type
    Malfunction
    Date Received
    December 9, 2025
    Date of Event
    November 18, 2025
    Report Date
    May 18, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY TO TREAT SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) DURING THE AQUABLATION THERAPY, WHILE COMPLETING THE FIRST TREATMENT PASS, THE AQUABEAM HANDPIECE GENERATED AN E05 CONSOLE ERROR. THE SURGEON ATTEMPTED MULTIPLE RESTARTS OF BOTH THE CPU AND THE CONSOLE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. CONSEQUENTLY, THE SURGEON ELECTED TO CONVERT THE PROCEDURE AND COMPLETE THE REMAINDER USING TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES FOR THE PATIENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407307 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male