BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 18848446 · Received March 6, 2024

    Report

    Report Number
    3012977056-2024-00056
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 14, 2024
    Report Date
    April 9, 2024
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    UDI-DI
    B614AB20001
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADVERSE EVENT PROBLEM COMPONENT CODE 4756: PER THE INSTRUCTIONS FOR USE, THE AQUABEAM MOTORPACK, A RE-USABLE COMPONENT OF THE AQUABEAM ROBOTIC SYSTEM, PROVIDES POWER TO THE AQUABEAM HANDPIECE BY MEANS OF DC MOTORS. ROOT CAUSE OF 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.

    Additional Manufacturer Narrative · 0

    H.11 ADDITIONAL MANUFACTURER NARRATIVE: THE AQUABEAM HANDPIECE WAS RETURNED FOR INVESTIGATION. NO VISUAL DEFECTS OR ANOMALIES WERE OBSERVED WITH THE HANDPIECE. FUNCTIONAL TESTING OF THE HANDPIECE TRIGGERED E22 ERROR ON DOCKING AND COULD BE CLEARED. A FULL AQUABLATION SIMULATION COULD BE CONDUCTED. REPORTED FAILURE MODE 1 WAS CONFIRMED, HOWEVER, THE SYSTEM DID NOT TRIGGER E31. THE HANDPIECE WAS DECONSTRUCTED AND VIEWED UNDER MAGNIFICATION. SIGNS OF FLUID INGRESS WERE OBSERVED ON THE ENCODER WHEEL. THUS, THE ROOT CAUSE WAS DETERMINED TO BE FLUID INGRESS. HOWEVER, THE SOURCE OF THE FLUID REMAINS UNDETERMINABLE THE LOG FILE REVIEW WAS ABLE TO CONFIRM THE REPORTED E23 AND E31 ERRORS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE AQUABEAM ROBOTIC SYSTEM SERIAL NUMBER (B)(6) AQUABEAM CONSOLE LOT NUMBER 21C01106 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WAS ONE REWORK THAT COULD BE POTENTIALLY RELATED TO THE REPORTED EVENT. THE LOT WAS SEGREGATED AND AFFECTED UNITS WERE REWORKED AND RE-INSPECTED AS PART OF OUR HANDPIECE FINAL INSPECTION PROCESS. UPON RE-INSPECTION, THE LOT MET ALL REQUIRED SPECIFICATIONS AND WAS DEEMED ACCEPTABLE TO BE RELEASED FOR DISTRIBUTION. THE AQUABEAM ROBOTIC SYSTEM USER MANUAL, UM0101 REV. F, STATES THE FOLLOWING: TABLE 5: SYSTEM DETECTED ERRORS AND FAULTS E22 - MOTORPACK ERROR RELEASE FOOT PEDAL AND CLICK X. 1) IF ERROR PERSISTS, RECONNECT HANDPIECE TO MOTORPACK. 2) IF ERROR CONTINUES, REPLACE HANDPIECE. 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 AN AQUABLATION PROCEDURE FOR SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH). PROCEPT BIOROBOTICS CORPORATION BECAME AWARE THAT DURING THE AQUABLATION PROCEDURAL SETUP, UPON CONNECTING THE AQUABEAM HANDPIECE AND AQUABEAM MOTORPACK, THE AQUABEAM ROBOTIC SYSTEM GENERATED MULTIPLE ERRORS SUCH AS "E22 - MOTORPACK ERROR", "E23 - MOTORPACK ERROR", "E31 - MOTORPACK ERROR", AND "E42 - MOTORPACK ERROR". DESPITE MULTIPLE TROUBLESHOOTING ATTEMPTS, THE ISSUE PERSISTED. A SECOND AQUABEAM HANDPIECE WAS TRIED, BUT THE ISSUE PERSISTED. FINALLY, A THIRD AQUABEAM HANDPIECE AND A SECOND AQUABEAM MOTORPACK WERE USED, WHICH RESOLVED THE ISSUE. THE REPORTED EVENT CAUSED A SURGICAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1582655 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION B614AB20001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male