BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 24413843 · Received February 23, 2026

    Report

    Report Number
    3012977056-2026-00027
    Event Type
    Malfunction
    Date Received
    February 23, 2026
    Date of Event
    February 3, 2026
    Report Date
    February 23, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427068
    PMA / PMN Number
    K240200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) BECAME AWARE THAT, DURING PROCEDURAL SETUP, THE HYDROS HANDPIECE MALFUNCTIONED. ANOTHER HYDROS HANDPIECE WAS OPENED AND FOUND TO BE NONFUNCTIONAL AS WELL. THE SYSTEM DISPLAYED A FIRMWARE ERROR CODE. ATTEMPTS TO PRIME THE SYSTEM AND CONNECT THE HANDPIECE TO THE MOTOR PACK WERE UNSUCCESSFUL. DUE TO THE DEVICE MALFUNCTION, THE PHYSICIAN ELECTED TO PROCEED WITH TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158499 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male