BEUDAMED
    FDA Recall 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 · Initiated March 6, 2019

    Recall

    Recall Number
    Z-1110-2019
    Event Number
    82462
    Firm
    PROCEPT BIOROBOTICS CORPORATION
    FEI Number
    3027788423
    Product Code
    PZP
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 6, 2019
    Terminated
    November 13, 2020
    Address
    900 Island Dr, Ste 101, Redwood City, CA, 94065-5176

    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.

    Action

    On 03/06/19, the firm, Procept BioRobotics, sent an"URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter via priority overnight mail with delivery confirmation to customers with affected devices. The letter the described the product, problem and actions to be taken. Customers were instructed to discontinue use and segregate affected devices. In addition, customers were asked to pass along the recall notice to all those who need to be aware of it within their organization and to complete and return the Recall Acknowledgement Form via Email: [email protected] or Fax to: +1.888.285.3777. Once the firm receives acknowledgement forms listing affected product, the firm will provide instructions on how to return affected product. Customers with questions are encouraged to call customer service at 1-650-232-7222. On 03/06/19, Courtesy Notification: Voluntary Medical Device Recall notices were mailed via priority overnight mail with delivery confirmation to customers who received non-affected devices. Customers who did not receive affected product were advised that no actions needed to be taken. Customers with questions are encouraged to call customer service at 1-650-232-7222. If you have any questions, please feel free to contact your local Aquablation Consultant or PROCEPT Customer Service by telephone at +1.650.232.7222 or email [email protected].

    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