BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 23879863 · Received December 23, 2025

    Report

    Report Number
    3012977056-2025-00304
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 10, 2025
    Report Date
    December 23, 2025
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPONENT CODE: 4756. AQUABEAM CONSOLE, A REUSABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM. 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) BECAME AWARE THAT DURING AQUABLATION THERAPY, THE AQUABEAM CONSOLE EXPERIENCED A SYSTEM FREEZE WITH AN UNKNOWN ERROR MESSAGE AFTER THE FIRST TREATMENT PASS. AS A RESULT, A SECOND AQUABLATION PASS COULD NOT BE PERFORMED. THE SURGEON COMPLETED THE PROCEDURE USING A RESECTION LOOP. 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
    2477340 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male