BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 11845627 · Received May 18, 2021

    Report

    Report Number
    3012977056-2021-00032
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 27, 2021
    Report Date
    November 21, 2021
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10 ADDITIONAL MANUFACTURER NARRATIVE: THE AQUABEAM HANDPIECE WAS RETURNED FOR INVESTIGATION. FUNCTIONAL INVESTIGATION REPLICATED THE REPORTED FAILURE MODE, AS THE HANDPIECE FAILED TO PRIME AT 50% AND 100% PUMP POWER. AFTER CONFIRMING THE REPORTED FAILURE MODE DURING ALIGNMENT A FLOWRATE TEST WAS CONDUCTED AND THE HANDPIECE FAILED TO JET AT PUMP LEVELS 1-3 (5-15% PUMP POWER). THE FLOWRATES FAILED PRODUCT SPECIFICATIONS, BUT PASSED AT PUMP POWER >6 (>30% PUMP POWER). THE FLOWRATE TEST CONFIRMED THE REPORTED EVENT. ADDITIONAL ANALYSIS OBSERVED A WARPED AND WAVY INLET VALVE AND FLASHING ON THE CIRCUMFERENTIAL EDGES OF THE VALVE. THESE ARE DUE TO THE POOR QUALITY CHECKS IN THE SUPPLIER INJECTION MOLDING OF THE INLET VALVES. THE INLET VALVE WAS REPLACED WITH A KNOWN GOOD VALVE AND WAS ABLE TO JET AT THE LOWER PUMP LEVELS AND THE FLOWRATES MEASURED WERE WITHIN SPECIFICATION AS SPECIFIED AQUABEAM HANDPIECE PRODUCT SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR SERIAL NUMBER (B)(6) AND THE LOT NUMBER 20C00674 FOR THE AQUABEAM HANDPIECE WERE PERFORMED, WHICH CONFIRMED THAT THERE WERE NO NONCONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE SYSTEM AND THE AQUABEAM HANDPIECE ARTICULATING ARMMET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. PROCEPT HAS IDENTIFIED A TREND ON WATERJET ALIGNMENT FAILURES AND A CORRECTIVE ACTION AND PREVENTIVE ACTION INVESTIGATION IS CURRENTLY UNDERWAY. THE AQUABEAM ROBOTIC SYSTEM INSTRUCTIONS FOR USE, IFU0101-00 REV. E, WAS REVIEWED AND STATES THE FOLLOWING: 8.23. STERILE: ALIGN WATERJET NOZZLE BY DOING THE FOLLOWING: A. TOGGLE THE TRUS STEPPER CRADLE (IF NEEDED) TO CENTER THE AQUABEAM HANDPIECE HYPERECHOIC ARTIFACT WITH VERTICAL YELLOW LINE B. PRESS THE FOOT PEDAL TO VISUALIZE POSITION OF WATERJET (RETRACT TRUS PROBE IF NEEDED BY USING KNOBS ON STEPPER) C. WATERJET NEEDS TO BE VISIBLE AT 3 OR 9 O'CLOCK D. 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. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE POOR QUALITY CHECKS DURING THE MANUFACTURING PROCESS OF THE INLET VALVE BY THE SUPPLIER. A CORRECTIVE ACTION AND PREVENTIVE ACTION HAS BEEN INITIATED BY PROCEPT TO ADDRESS THIS ISSUE. 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 INPROCESS. 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 · 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
    738258 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION AB2000 B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 Male