PROCEPT BIOROBOTICS CORPORATION Recall 88337
Description: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
PROCEPT BIOROBOTICS CORPORATION Recall 88337 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2330-2021 |
| Event ID | 88337 |
| Event Description | AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System. |
| Product Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20210901 |
| Device Code Info | Lot: 21C00226; 21C00290; 21C00304; 21C00359; 21C00373; 21C00464; 21C00465; 21C00527 |
| Center Classification Date | 20210820 |
| Recall Initiation Date | 20210709 |
| Recalling Firm | PROCEPT BIOROBOTICS CORPORATION |
| Initial Notification | Letter |
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