BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUABEAM HANDPIECE

    MDR report key: 18815925 · Received March 1, 2024

    Report

    Report Number
    18815925
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Date of Event
    June 15, 2023
    Report Date
    November 6, 2023
    Manufacturer
    PROCEPT BIOROBOTICS CORPORATION
    Product Code
    PZP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ERROR MESSAGE ON CONSOLE, NEW HANDPIECE OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932515 AQUABEAM HANDPIECE FLUID JET REMOVAL SYSTEM PZP PROCEPT BIOROBOTICS CORPORATION HP2000 23C01200

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male