BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM ROBOTIC SYSTEM

    MDR report key: 16218871 · Received January 20, 2023

    Report

    Report Number
    3012977056-2023-00007
    Event Type
    Malfunction
    Date Received
    January 20, 2023
    Date of Event
    December 21, 2022
    Report Date
    January 20, 2023
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    PMA / PMN Number
    DEN170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL MANUFACTURER NARRATIVE: DEVICE EVALUATION BY MANUFACTURER: THE AQUABEAM HANDPIECE WAS NOT RETURNED FOR INVESTIGATION AS IT WAS DISPOSED OF AT THE USER FACILITY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) AB2000-B / SERIAL NUMBER: (B)(4) AND AQUABEAM HANDPIECE / LOT NUMBER: 22C03392 WAS CONDUCTED, WHICH CONFIRMED THAT THERE WERE NO NON-CONFORMANCES, FAILURES, DISCREPANCIES, OR MISSED STEPS DURING THE MANUFACTURING PROCESS THAT COULD BE RELATED TO THE REPORTED EVENT. THE REVIEW INDICATED THAT THE SYSTEM MET ALL DESIGN AND MANUFACTURING SPECIFICATIONS WHEN RELEASED FOR DISTRIBUTION. THE CURRENT USER MANUAL UM0101-00 REV. F, AQUABEAM ROBOTIC SYSTEM USER MANUAL, US, ENGLISH WAS REVIEWED. SECTION 11.2.7 STERILE: MOTORPACK DRAPING AND DOCKING WITH THE AQUABEAM HANDPIECE CONTAINS THE NOTE TO, "VERIFY THE MOTORPACK IS SECURELY ENGAGED TO THE AQUABEAM HANDPIECE BY ATTEMPTING TO PULL THE AQUABEAM HANDPIECE OFF OF THE MOTORPACK. THE AQUABEAM HANDPIECE SHOULD REMAIN CONNECTED TO THE MOTORPACK IF PROPERLY ENGAGED." DOCK THE MOTORPACK TO THE AQUABEAM HANDPIECE: O VERIFY AQUABEAM HANDPIECE NOZZLE POSITION (I.E. THE MOVEMENT OF THE BLUE LED) HOMES TO THE BASE OF THE AQUABEAMHANDPIECE (FULLY PROXIMAL). O APPLY STERILE TAPE OVER THE CONNECTION BETWEEN AQUABEAM HANDPIECE AND MOTORPACK TO SEAL IT. O KEEP THE MOTORPACK AND THE AQUABEAM HANDPIECE ASSEMBLY WITH THE SCOPE CLAMP ASSEMBLY IN A SECURE AND STERILE ENVIRONMENT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE ESTABLISHED AS THE HANDPIECE WAS NOT RETURNED FOR INVESTIGATION. 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 (PROCEPT) BECAME AWARE THAT DURING THE AQUABLATION PROCEDURE, THE AQUABEAM HANDPIECE WAS UNABLE TO BE ENGAGED TO THE AQUABEAM MOTORPACK DESPITE MULTIPLE ATTEMPTS BEING MADE. THE HANDPIECE WAS REPLACED WITH A NEW HANDPIECE UNIT AND THE PROCEDURE WAS CONTINUED THROUGH SUCCESSFUL COMPLETION. THE REPORTED EVENT CAUSED A SURGICAL PROCEDURAL DELAY OF OVER 20 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT DUE TO THE PROCEDURAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1984601 AQUABEAM ROBOTIC SYSTEM FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Male