BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 24140553 · Received January 21, 2026

    Report

    Report Number
    3012977056-2026-00006
    Event Type
    Malfunction
    Date Received
    January 21, 2026
    Date of Event
    January 8, 2026
    Report Date
    April 24, 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.

    Additional Manufacturer Narrative · 0

    THE HYDROS HANDPIECE WAS RETURNED FOR INVESTIGATION. THE TREATMENT LOG FILES WERE REVIEWED AND FOUND THAT BOTH E206 AND E254 ERRORS OCCURRED; CONFIRMING THE REPORTED FAILURE. DURING FUNCTIONAL TESTING, AN E206 ERROR WAS TRIGGERED WHICH COULD NOT BE CLEARED. IT WAS FOUND THAT THE HIGH-PRESSURE HOSE CONTRIBUTED TO THE REPORTED FAILURE. THE ROOT CAUSE WAS DETERMINED TO BE A COMPONENT FAILURE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) AND HH1000/LOT NUMBER 25C05468 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 EVENT. THE REVIEW INDICATED THAT THE DEVICE MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE HYDROS ROBOTIC SYSTEM USER MANUAL, UM0401-00 REV C STATES THE FOLLOWING: 17.2 SYSTEM DETECTED ERRORS IN TABLE 5 ERROR MESSAGES FOR E206, E254. 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.

    Description of Event or Problem · 0

    A MALE PATIENT UNDERWENT AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE DURING AQUABLATION THERAPY THAT THE HYDROS ROBOTIC SYSTEM GENERATED THE ERROR CODES "E206 - MOTORPACK ERROR" AND "E254 - MOTORPACK ERROR". DESPITE TROUBLESHOOTING ATTEMPTS, THE ISSUES PERSISTED. THE REPORTED EVENT RESULTED IN THE PROCEDURE BEING ABORTED WHILE THE PATIENT WAS UNDER ANESTHESIA. 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
    202867 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male