BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 21453861 · Received February 24, 2025

    Report

    Report Number
    3012977056-2025-00056
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 5, 2025
    Report Date
    June 13, 2025
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427051
    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

    THE HYDROS HANDPIECE WAS NOT RETURNED FOR INVESTIGATION. THREE (3) GOOD FAITH EFFORTS WERE MADE BY PROCEPT TO RETRIEVE THE HYDROS HANDPIECE WITHOUT SUCCESS. THE TREATMENT LOG FILES WERE REVIEWED AND FOUND OCCURRENCES OF E917 ERRORS. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE ESTABLISHED AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR HY1000/SERIAL NUMBER (B)(6) AND HYDROS HANDPIECE/LOT NUMBER 24C03673 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'S USER MANUAL, UM0401-00-01, REV. B WAS REVIEWED. TABLE 5 ERROR MESSAGES: E917: RECONNECT COMPONENT 1. RELEASE FOOT PEDAL. 2. CHECK STATUS PANEL FOR SOURCE OF ISSUES. 3. RECONNECT OR REPLACE COMPONENT AS NEEDED UNTIL STATUS BECOMES GREEN. 4. CLICK OK TO CLEAR ALERT; 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.

    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 BECAME AWARE THAT DURING AQUABLATION THERAPY AND WHILE THE PATIENT WAS IN THE OPERATING ROOM UNDER ANESTHESIA, THE HANDPIECE ON THE HYDROS ROBOTIC SYSTEM GENERATED ERROR CODE ¿E917 ¿ CYSTOSCOPE SENSOR TIP DISCONNECTED¿. THE SURGEON OPTED TO SWITCH TO AN ALTERNATE HANDPIECE FOR THE HYDROS ROBOTIC SYSTEM; HOWEVER, THE SAME ERROR CODE PERSISTED. A THIRD HANDPIECE WAS SUBSEQUENTLY OPENED AND USED, ALLOWING THE PROCEDURE TO BE COMPLETED WITHOUT FURTHER ISSUES. THE REPORTED EVENT CAUSED A SURGICAL 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
    401939 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427051

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male