Recall Z-2330-2021 ยท PZP Fluid Jet Removal System
PROCEPT BIOROBOTICS CORPORATION
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
| Date | Jul 9, 2021 |
| Status | Open, Classified |
| 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. |
| Root cause | Component change control |
| Action | On 07/09/21 Voluntary Medical Device Recall notices were mailed to customers. Customers were asked to take the following actions if tip detachment occurs: If the scope tube tip detaches from the telescoping tube before insertion into the patient during preparation, the Handpiece must be replaced with a new Handpiece. If the scope tube tip detaches after the Handpiece has been inserted into the patient, this is seen cystoscopically and the Handpiece must be removed and replaced with a new Handpiece. In the event that the scope tube tip separates from the Handpiece entirely, the scope tube tip |
| Quantity | 608 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202961 | AquaBeam Robotic System Procept Biorobotics, Corporation, Mar 11, 2021 |