BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 21800282 · Received April 8, 2025

    Report

    Report Number
    3012977056-2025-00122
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 19, 2025
    Report Date
    September 30, 2025
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 TOWER TOUCHSCREEN WAS NOT RETURNED FOR INVESTIGATION. THREE (3) GOOD FAITH EFFORTS WERE MADE BY PROCEPT TO RETRIEVE THE HYDROS TOWER TOUCHSCREEN AND TREATMENT LOG FILES WITHOUT SUCCESS. BASED ON ANALYSIS FROM A PROCEPT REPRESENTATIVE AT THE HOSPITAL SITE, THE TOWER'S TOUCH RESPONSE WAS BEING INTERFERED BY A WET MONITOR DRAPE WHICH LIKELY WAS DUE TO USER HANDLING WITH WET GLOVES. THE REPORTED FAILURE COULD NOT BE REPRODUCED AND THE ROOT CAUSE IS UNDETERMINABLE. THE HYDROS TOWER TOUCHSCREEN IS IMPORTED FROM A SUPPLIER AND NOT MANUFACTURED AT PROCEPT BIOROBOTICS. THE RECEIVING INSPECTION RECORDS FOR TOWER TOUCHSCREEN LOT 24A14824 WERE REVIEWED. NO NON-CONFORMANCES OR REWORKS WERE ISSUED BY PROCEPT BIOROBOTICS FOR THIS LOT. THE REVIEW INDICATED THE DEVICE MET ALL REQUIRED SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL, UM0401-00-01 REV. C, US, ENGLISH WAS REVIEWED. 4-3.1 PRECAUTIONS: GENERAL - FOLLOW THE PROVIDED CLEANING AND DISINFECTION INSTRUCTIONS. OTHER CLEANING OR DISINFECTION METHODS MAY CAUSE DAMAGE TO THE DEVICE. 10.2 AQUABLATION THERAPY PROCEDURE OUTLINE 5A STERILE DRAPING - TOUCHSCREEN, PATIENT, AND HANDPIECE ARM - DRAPE SURGEON TOUCHSCREEN (STERILE) BY HOOKING THE INTERIOR OF THE DRAPE OVER EACH CORNER OF THE TOUCHSCREEN AND ADJUSTING THE FIT AND FLATNESS OVER THE TOUCHSCREEN SURFACE. - CAUTION: FOLLOW UNIVERSAL STERILE TECHNIQUE TO PREPARE THE COMPONENTS OF THE DEVICE FOR USE WITHIN THE STERILE OPERATING FIELD. 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 THAT DURING AQUABLATION THERAPY, THE HYDROS TOUCHSCREENS STOPPED FUNCTIONING. TROUBLESHOOTING RESOLVED THE ISSUE, AND THE PROCEDURE WAS COMPLETED. THE REPORTED EVENT CAUSED A PROCEDURAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740854 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male