BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11795046 · Received May 7, 2021

    Report

    Report Number
    3012977056-2021-00029
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 22, 2021
    Report Date
    August 14, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H10: ADDITIONAL MANUFACTURER NARRATIVE: H6: ADVERSE EVENT PROBLEM: INVESTIGATION FINDINGS: 4247 - INCOMPLETE DEVICE RETURNED FOR INVESTIGATION. THE AQUABEAM HANDPIECE WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION CONFIRMED THAT THE HANDPIECE PUMP CARTRIDGE WAS MISSING AND HAD BEEN SEVERED FROM THE HIGH PRESSURE HOSE. COMPREHENSIVE FUNCTIONAL TESTING COULD NOT BE CONDUCTED TO THE CONDITION IN WHICH THE HANDPIECE WAS RETURNED FOR INVESTIGATION; THEREFORE, THE REPORTED FAILURE MODE COULD NOT BE REPLICATED. ALTHOUGH THE REPORTED FAILURE COULD NOT BE CONFIRMED DUE TO THE CONDITION IN WHICH THE HANDPIECE WAS RETURNED FOR INVESTIGATION, PROCEPT HAS IDENTIFIED A TREND ON WATERJET ALIGNMENT FAILURES, WHICH IS CURRENTLY BEING INVESTIGATED UNDER THE CAPA PROCESS. A TOTAL OF 40 COMPLAINTS HAVE BEEN REPORTED TO DATE ON THIS ISSUE. THE AQUABEAM ROBOTIC SYSTEM'S INSTRUCTIONS FOR USE (IFU), IFU (B)(4) REV. B, WAS REVIEWED AND STATES THE FOLLOWING: SECTION 8.23. STERILE: ALIGN WATERJET NOZZLE BY DOING THE FOLLOWING: TOGGLE THE TRUS STEPPER CRADLE (IF NEEDED) TO CENTER THE AQUABEAM HANDPIECE HYPERECHOIC ARTIFACT WITH VERTICAL YELLOW LINE; PRESS THE FOOT PEDAL TO VISUALIZE POSITION OF WATERJET (RETRACT TRUS PROBE IF NEEDED BY USING KNOBS ON STEPPER); WATERJET NEEDS TO BE VISIBLE AT 3 OR 9 O'CLOCK; IF SLIGHTLY OFF, DEPRESS THE BLACK BUTTON ON THE MAG BLOCK (LOCATED ON THE HANDPIECE ARTICULATING ARM) AND ROTATE THE AQUABEAM HANDPIECE AXIS WHILE STEPPING ON FOOT PEDAL TO ALIGN JETS TO 3 AND 9 O'CLOCK POSITION. COMPREHENSIVE FUNCTIONAL TESTING COULD NOT BE PERFORMED WITH THE RETURNED HANDPIECE, THUS THE ROOT CAUSE COULD NOT BE ESTABLISHED. PROCEPT HAS IDENTIFIED A TREND ON WATERJET ALIGNMENT FAILURES, WHICH IS CURRENTLY BEING INVESTIGATED UNDER THE CAPA PROCESS. SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE MANUFACTURER'S PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE OF REPORTED EVENT HAS NOT YET BEEN ESTABLISHED. INVESTIGATION BY MANUFACTURER IS CURRENTLY IN-PROCESS.

    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 THERE WAS NO MOVEMENT OF THE HIGH-VELOCITY WATERJET ON THE AQUABEAM HANDPIECE. SEVERAL TROUBLESHOOTING STEPS WERE PERFORMED; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE AQUABEAM HANDPIECE WAS REPLACED AND THE AQUABLATION PROCEDURE WAS CONTINUED THROUGH SUCCESSFUL COMPLETION. THE REPORTED EVENT CAUSED A SURGICAL PROCEDURAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES WITH THE PATIENT BECAUSE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688668 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1