BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 24945395 · Received April 21, 2026

    Report

    Report Number
    3012977056-2026-00087
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    April 3, 2026
    Report Date
    April 21, 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 WAS SCHEDULED FOR AQUABLATION THERAPY FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT DURING AQUABLATION THERAPY, WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE HYDROS ROBOTIC SYSTEM EXPERIENCED A COMMUNICATION ERROR CODE (E480) WITH THE POWER DISTRIBUTION UNIT. THE ERROR COULD NOT BE RESOLVED DESPITE TROUBLESHOOTING ATTEMPTS. AS A RESULT, THE TREATING SURGEON MADE THE DECISION TO ABORT THE PROCEDURE AND PROCEED WITH A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). 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
    1006712 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male