BEUDAMED
    FDA Enforcement Class II Ongoing

    AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

    Recall: Z-2330-2021 · Reported September 1, 2021

    Enforcement

    Recall Number
    Z-2330-2021
    Event ID
    88337
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    PROCEPT BIOROBOTICS CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 1, 2021
    Initiation Date
    July 9, 2021
    Classification Date
    August 20, 2021
    Address
    900 Island Dr Ste 101, N/A, Redwood City, CA, 94065-5176, United States

    Description

    AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

    Reason

    Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

    Code Info

    Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of FL, IL, TX, WI, AZ, AR, MI, WV, SD, PA, CA, DC, NJ, NY, GA, IN, VA, TN and the countries of Austria, Switzerland, Germany, Spain, France, UK, Italy.

    Quantity

    608