BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 24945393 · Received April 21, 2026

    Report

    Report Number
    3012977056-2026-00088
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 21, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPONENT CODE = 4756; AQUABEAM FOOTPEDAL IS A RE-USABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, WHICH CONTAINS FOOT-ACTIVATED MOTION BUTTON TO ACTIVATE THE HIGH-VELOCITY WATERJET DURING TREATMENT MODE. 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 WAS SCHEDULED FOR AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE WATER JET WOULD NOT ACTIVATE WHEN THE SURGEON STEPPED ON THE FOOT PEDAL. THE ISSUE COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS. AS A RESULT, THE PROCEDURE HAD TO BE ABORTED. 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
    1006716 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male