BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11721156 · Received April 23, 2021

    Report

    Report Number
    3012977056-2021-00023
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 25, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.3 DEVICE EVALUATION BY MANUFACTURER: THE AQUABEAM CONSOLE WAS RETURNED FOR INVESTIGATION. THE REPORTED "E03 - CONSOLE ERROR" MESSAGE WAS ABLE TO BE REPRODUCED IN ADDITION TO A "E02 - CONSOLE ERROR" MESSAGE. E02 WAS TRIGGERED WHEN PRIMING AT 50% AND E03 WAS TRIGGERED PRIMING AT 100% PUMP POWER. THE ENCODER WAS OBSERVED TO HAVE IRREGULAR SIGNALS USING AN OSCILLOSCOPE, WHICH WAS A SIGN OF A MISALIGNED ENCODER WHEEL. CONTAMINANTS OBSERVED ON THE ENCODER WERE TESTED TO BE PUMP CARTRIDGE PISTON OIL AND IS FUNNELED THROUGH THE PUMP NEST INTAKE. HOWEVER, THIS CONTAMINANT IS A LESSER CONTRIBUTOR TO THE E02/E03 COMPARED TO A MISALIGNED ENCODER. A REVIEW OF THE AQUABEAM ROBOTIC SYSTEM'S LOG FILE CONFIRMED THE E03 ERROR MESSAGE IN ADDITION TO AN E02 ERROR MESSAGE. THE PROCEDURE WAS ABORTED ALTOGETHER. A TOTAL OF 39 MINUTES AND 15 SECONDS OF DOWNTIME, FROM THE FIRST E03 ERROR APPEARING AT 9:35:26 TO THE SYSTEM SHUTTING DOWN AT 10:14:41. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WERE CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES GENERATED DURING THE MANUFACTURING PROCESS OF THIS SYSTEM AND/OR AQUABEAM CONSOLE ASSOCIATED TO THIS EVENT. THE REVIEW INDICATED THAT THE SYSTEM AND/OR AQUABEAM CONSOLE MET ALL REQUIRED SPECIFICATIONS UPON RELEASE FOR DISTRIBUTION. A REVIEW OF SIMILAR COMPLAINTS CONFIRMED THAT THERE ARE THREE (3) OTHER SIMILAR EVENTS. THE AQUABEAM ROBOTIC SYSTEM USER MANUAL, UM0101-00 REV. E, STATES: TABLE 5 SYSTEM DETECTED ERRORS AND FAULTS "E02 - CONSOLE ERROR RELEASE FOOT PEDAL AND CLICK X. IF ERROR PERSISTS, TURN OFF AND TURN ON CONSOLE." "E03 - CONSOLE ERROR RELEASE FOOT PEDAL AND CLICK X. IF ERROR PERSISTS, TURN OFF AND TURN ON CONSOLE." THE ROOT CAUSE OF THE ENCODER MISALIGNMENT WAS DUE TO THE INCORRECT SPACER TOOL BEING USED. A NEW SPACER TOOL WAS IMPLEMENTED ON (B)(6) 2020 TO ADDRESS ENCODER ALIGNMENT ISSUES. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY INPROCESS.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING THE AQUABLATION PROCEDURE "E02 - CONSOLE ERROR" WAS GENERATED BY THE AQUABEAM ROBOTIC SYSTEM. THE ERROR MESSAGE COULD NOT BE CLEARED DURING TROUBLESHOOTING STEPS. THEREFORE, THE TREATING PHYSICIAN PROCEEDED TO STOP THE PROCEDURE AND RESCHEDULED FOR A LATER DATE. THERE WERE NO ADVERSE CONSEQUENCES TO PATIENT'S HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616015 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1