MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM HANDPIECE; FLUID JET REMOVAL SYSTEM

Model Number	HP2000
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure, the surgeon and the tech noticed that the aquablation handpiece was malfunctioning.The reps were present and tried to troubleshoot, to no avail.The device was replaced with a new handpiece.No patient harm.

• Brand Name: AQUABEAM HANDPIECE
• Common Device Name: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 150 baytech drive; san jose CA 95134
• MDR Report Key: 23485249
• Report Number: 23485249
• Device Sequence Number: 10494076
• Product Code: PZP
• UDI-Device Identifier: 00850055427037
• UDI-Public: (01)00850055427037(17)270430
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2025
• Report Date (Section F): 10/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HP2000
• Device Catalogue Number: HP2000-C
• Device Lot Number: 25C01778
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Date Report Sent to FDA: 10/09/2025