BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 24471840 · Received February 27, 2026

    Report

    Report Number
    3012977056-2026-00031
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    February 11, 2026
    Report Date
    May 26, 2026
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427068
    PMA / PMN Number
    K240200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AQUABLATION THERAPY, THE HYDROS ROBOTIC SYSTEM DISPLAYED MULTIPLE ERROR CODES. THE FIRST TREATMENT PASS WAS COMPLETED SUCCESSFULLY. ALTHOUGH THE SURGEON CONSIDERED PERFORMING A SECOND TREATMENT PASS, THEY ELECTED TO TRANSITION TO AN OLYMPUS LOOP TO COMPLETE THE RESECTION. 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
    51135 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male