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).
- Company
- Procept Biorobotics Corporation
- Recall Initiated
- March 6, 2019
- Terminated
- November 13, 2020
- Recall Number
- Z-1110-2019
- Quantity
- 214
- Firm Location
- Redwood City, CA
Reason for Recall
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.
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.
Lot / Code Info
Domestic Lots: 18C00681, 18C00770, 18C00852, 18C01244. Foreign Lots: 18C00799, 18C00844, 18C00985, 18C01024, 18C01044, 18C01234
Root Cause
Process control
Action Taken
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: cs@procept-biorobotics.com 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 cs@procept-biorobotics.com.