BEUDAMED
    FDA Adverse Event Death Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 23330378 · Received October 17, 2025

    Report

    Report Number
    3012977056-2025-00271
    Event Type
    Death
    Date Received
    October 17, 2025
    Date of Event
    August 27, 2025
    Report Date
    December 3, 2025
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427068
    PMA / PMN Number
    K240200
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ROBOTIC SYSTEM IS A REUSABLE DEVICE; THEREFORE, IT IS CURRENTLY IN THE POSSESSION OF THE USER FACILITY. THE INVESTIGATION OF THIS EVENT CONSISTED OF A REVIEW OF THE TREATMENT LOG FILES, DEVICE HISTORY RECORD (DHR), AND USER MANUAL (UM). THE HYDROS ROBOTIC SYSTEM'S TREATMENT LOG FILES WERE REVIEWED, WHICH CONFIRMED NO MALFUNCTION OCCURRED. THE REVIEW OF THE TREATMENT LOG FILES REVEALED THAT THE HYDROS ROBOTIC SYSTEM FUNCTIONED AS INTENDED, AS NO MALFUNCTION WAS OBSERVED DURING AQUABLATION THERAPY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) 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 (UM), UM0401-00-01, REV. C, WAS REVIEWED. 3. CONTRAINDICATIONS: DO NOT USE THE HYDROS ROBOTIC SYSTEM IN PATIENTS WHO DO NOT MEET THE INDICATION FOR THE SYSTEM'S INTENDED USE. 4.2.3 WARNINGS: PROCEDURE: AS WITH ANY SURGICAL UROLOGIC PROCEDURE, POTENTIAL PERIOPERATIVE RISKS OF THE AQUABLATION PROCEDURE INCLUDE THE FOLLOWING, SOME OF WHICH MAY LEAD TO SERIOUS OUTCOMES AND MAY REQUIRE INTERVENTION: O EMBOLISM. IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOUR (4) DAYS POST-AQUABLATION THERAPY. THE TREATING SURGEON REPORTED THAT THE PATIENT HAD A MEDICAL HISTORY OF MILD CARDIAC ISSUES WITH HYPOTENSION AND WAS NOT ON ANY MEDICATION, SUCH AS ANTI-COAGULANTS, PRIOR TO THE PROCEDURE. THE PATIENT WAS CLEARED FOR SURGERY, WHICH PROCEEDED SMOOTHLY WITHOUT ANY ISSUES, AND WAS DISCHARGED HOME WITH A FOLEY BALLOON CATHETER IN PLACE. THE PATIENT WAS THEN REPORTED TO HAVE PASSED AWAY SEVERAL DAYS LATER. THE TREATING SURGEON BELIEVES IT WAS DUE TO A PULMONARY EMBOLISM (PE) AND IS UNRELATED TO THE PERFORMANCE OF THE HYDROS ROBOTIC SYSTEM OR AQUABLATION THERAPY, AND CONFIRMED THAT NO AUTOPSY WILL BE PERFORMED. THE HYDROS ROBOTIC SYSTEM'S USER MANUAL (UM) LISTS EMBOLISM AS A POTENTIAL RISK OF AQUABLATION THERAPY. BASED ON THE INFORMATION OBTAINED FROM THE TREATING SURGEON, PLUS A REVIEW OF THE TREATMENT LOG FILES, UM, AND DHR, THE EVENT IS CONSIDERED TO BE NOT DEVICE-RELATED. 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) ON (B)(6) 2025. PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE THAT ON (B)(6) 2025, FOUR DAYS POST AQUABLATION THERAPY, THE PATIENT PASSED AWAY. THE TREATING SURGEON REPORTED THAT THE PATIENT HAD A MEDICAL HISTORY OF MILD CARDIAC ISSUES WITH HYPOTENSION AND WAS NOT ON ANY MEDICATION, SUCH AS ANTI-COAGULANTS, PRIOR TO THE PROCEDURE. THE PATIENT WAS CLEARED FOR SURGERY, WHICH PROCEEDED SMOOTHLY WITHOUT ANY ISSUES, AND WAS DISCHARGED HOME WITH A FOLEY BALLOON CATHETER IN PLACE. THE PATIENT WAS THEN REPORTED TO HAVE PASSED AWAY SEVERAL DAYS LATER. THE TREATING SURGEON BELIEVES IT WAS DUE TO A PULMONARY EMBOLISM (PE) AND IS UNRELATED TO THE PERFORMANCE OF THE AQUABEAM ROBOTIC SYSTEM OR AQUABLATION THERAPY AND CONFIRMED THAT NO AUTOPSY WILL BE PERFORMED. NO MALFUNCTION OF THE AQUABEAM ROBOTIC SYSTEM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2765971 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death