BEUDAMED
    FDA Enforcement Class II Terminated

    AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).

    Recall: Z-1110-2019 · Reported April 17, 2019

    Enforcement

    Recall Number
    Z-1110-2019
    Event ID
    82462
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    PROCEPT BIOROBOTICS CORPORATION
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2019
    Initiation Date
    March 6, 2019
    Classification Date
    April 8, 2019
    Termination Date
    November 13, 2020
    Address
    900 Island Dr Ste 101, N/A, Redwood City, CA, 94065-5176, United States

    Description

    AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).

    Reason

    Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.

    Code Info

    Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234

    Distribution

    Worldwide Distribution: US (nationwide) state to: TX, FL, IN, CA, IL, VA, MI, PA.; and (OUS) countries of: Italy, Germany, France, Poland, United Kingdom, Spain, Canada and Australia.

    Quantity

    214