BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 23992570 · Received January 7, 2026

    Report

    Report Number
    3012977056-2025-00311
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 7, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427068
    PMA / PMN Number
    K240200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 THE FIRST TREATMENT PASS, THE HYDROS ROBOTIC SYSTEM DISPLAYED ERROR E250 - Z ENCODER SPEED IS MORE THAN 120% OF THE DESIRED SPEED FOR OVER 10MS. THE CUSTOMER CLEARED THE ERROR BY REBOOTING. DURING THE SECOND TREATMENT PASS, THE SYSTEM DISPLAYED ERROR E250 AND E251: Z ENCODER SPEED WAS LESS THAN 80% OF THE DESIRED SPEED FOR OVER 10MS. DUE TO THE INABILITY TO RESOLVE THE ISSUE, THE TREATING SURGEON DECIDED TO ABORT THE PROCEDURE. 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
    59459 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male