BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM SYSTEM

    MDR report key: 8638811 · Received May 23, 2019

    Report

    Report Number
    3012977056-2019-00025
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    March 7, 2019
    Report Date
    May 21, 2021
    Manufacturer
    PROCEPT BIOROBOTICS
    Product Code
    PZP
    PMA / PMN Number
    DEN170024
    Removal / Correction Number
    3012977056-030619-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H. 11 CORRECTED DATA: FOR CORRECTED DATA, PLEASE REFER TO SECTION H.1 TYPE OF REPORTABLE EVENT, FOLLOW-UP #1 WAS INCORRECTLY SUBMITTED AS "SERIOUS INJURY".

    Additional Manufacturer Narrative · 0

    H.10. [X] ADDITIONAL MANUFACTURER NARRATIVE THE AQUABEAM HANDPIECE WAS RETURNED FOR INVESTIGATION. THE AQUABEAM HANDPIECE WAS CONNECTED TO AN AQUABEAM SYSTEM AND A TEST AQUABLATION TREATMENT RUN WAS PERFORMED; A LEAK WAS OBSERVED. THE HANDPIECE WAS DISCONNECTED, THE OUTER SHELL WAS REMOVED, AND THE HANDPIECE WAS CONNECTED AGAIN TO THE AQUABEAM SYSTEM AND A TEST TREATMENT RUN WAS PERFORMED WITHOUT THE OUTER SHELL. A LEAK WAS OBSERVED AT THE P1080 PROBE TUBE TO P1160 PUMP CARTRIDGE DISTAL CRIMP LASER WELD. THE WELD LEAK RESULTED IN SALINE LEAKING ON THE SENSOR BOARD, WHICH CAUSED AN R POSITION LOST ERROR. THE ERROR IS DISPLAYED TO THE USER AS AN E22 ERROR ON THE AQUABEAM CPU. THE INVESTIGATION CONFIRMED THE WELD LEAK LIKELY CAUSED THE REPORTED E22 ERROR. THE REPORTED EVENT WAS CONFIRMED DURING THE INVESTIGATION. ROOT CAUSE INVESTIGATION INTO THIS ISSUE DETERMINED THAT THE MICRO-CRACK THAT CAN DEVELOP IN A WELD JOINT WITHIN THE HANDPIECE, AND CAUSE THE FAILURE MODE, IS DUE TO VARIABILITY IN A SINGLE PASS WELDING PROCESS. THE CONTRIBUTING FACTORS TO THE VARIABILITY WERE IDENTIFIED THROUGH A FISH BONE ANALYSIS AND ARE LISTED BELOW. 1. WELD PLACEMENT 2. COMPONENT GAP 3. WELD DESIGN 4. WELD INSPECTION 5. MATERIAL COMPATIBILITY 6. INCREASE IN PRODUCTION VOLUME MULTIPLE LONG-TERM CORRECTIVE AND PREVENTIVE ACTIONS WERE ESTABLISHED TO FURTHER ADDRESS THE UNDERLYING FACTORS IDENTIFIED. THIS EVENT IS PART OF RECALL 3012977056-030619-001-R. 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

    DURING AN AQUABLATION PROCEDURE, E22 (R MOTION ERROR) MESSAGE OCCURRED. AQUABEAM HANDPIECE WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429176 AQUABEAM SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS 310301 18C00153

    Patients

    Seq Age Sex Outcome Treatment
    1