BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 23992585 · Received January 7, 2026

    Report

    Report Number
    3012977056-2025-00312
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 9, 2025
    Report Date
    March 25, 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

    THE HYDROS HANDPIECE WAS NOT RETURNED FOR INVESTIGATION. GOOD FAITH ATTEMPTS WERE MADE BY PROCEPT TO RETRIEVE THE HYDROS HANDPIECE WITHOUT SUCCESS. THE TREATMENT LOG FILES WERE REVIEWED AND FOUND E251, E451, AND E250 ERRORS, CONFIRMING THE REPORTED FAILURE. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE HYDROS HANDPIECE WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) AND HYDROS HANDPIECE/LOT NUMBER 25C05373 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED FAILURE. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM), UM0401-00-01, REV. C, WAS REVIEWED. 17.2: E250 SYSTEM ALERT 1. RELEASE FOOT PEDAL. 2. CLICK OK TO CLEAR ALERT. 3. IF ALERT PERSISTS, CHECK STATUS PANEL. 4. RECONNECT OR REPLACE COMPONENT IF NEEDED; MAY REQUIRE REALIGNMENT AND REPLANNING IF ISSUE PERSISTS, CALL PROCEPT BIOROBOTICS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    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 EXCEEDED 120% OF THE DESIRED SPEED FOR OVER 10MS. A NEW AQUABEAM HANDPIECE WAS OPENED FOR THE SECOND TREATMENT PASS, BUT ANOTHER UNSPECIFIED ERROR OCCURRED, AND 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
    55310 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male