BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROS ROBOTIC SYSTEM

    MDR report key: 21095811 · Received January 7, 2025

    Report

    Report Number
    3012977056-2025-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 10, 2024
    Report Date
    June 17, 2025
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    00850055427068
    PMA / PMN Number
    DEN170024
    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 RETURNED FOR INVESTIGATION. THE TREATMENT LOG FILES WERE REVIEWED WHICH FOUND OCCURRENCES OF E917 ERRORS; CONFIRMING THE REPORTED FAILURE. DURING FUNCTIONAL TESTING, AN E917 ERROR WAS TRIGGERED. EVIDENCE OF SALINE INGRESS WAS OBSERVED ON THE HYDROS HANDPIECE WHICH COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE ROOT CAUSE WAS DETERMINED TO BE A SUPPLIER ISSUE AND IS BEING ADDRESSED THROUGH PROCEPT'S QUALITY MANAGEMENT SYSTEM. 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 FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION (PROCEPT) BECAME AWARE DURING AQUABLATION THERAPY, THE HYDROS ROBOTIC SYSTEM GENERATED AN "E917 - CYSTOSCOPE NOT DETECTED BY SYSTEM." DESPITE TROUBLESHOOTING ATTEMPTS, THE ERRORS PERSISTED AND COULD NOT BE CLEARED. THE ISSUE WAS ABLE TO BE RESOLVED AFTER REPLACING MULTIPLE HYDROS HANDPIECES. THE REPORTED EVENT CAUSED A PROCEDURAL DELAY OF OVER 20 MINUTES WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883636 HYDROS ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION 00850055427068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male